Brief Summary
To evaluate the efficacy of three doses of quinagolide administered as an extended-release vaginal ring compared to placebo on reduction of moderate to severe endometriosis-related pain
Brief Title
Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain
Categories
Completion Date
Completion Date Type
Actual
Conditions
Endometriosis-related Pain
Eligibility Criteria
Inclusion Criteria:
* Pre-menopausal females aged ≥18 years at time of signing informed consent(s) with regular menstrual cycles.
* Body mass index (BMI) of 18-42 kg/m2 (both inclusive) at screening.
* Initial confirmation of endometriosis by laparoscopy or laparotomy within the last 10 years before the run-in visit or visualization of persistent endometrioma by repeat ultrasound.
* Transvaginal ultrasound documenting a uterus with no clinically significant abnormalities and presence of at least one ovary with no clinically significant abnormalities (with the exception of endometrioma) at the run-in visit.
* Eligible participants experienced moderate to severe endometriosis-related pain, which was defined as at the run-in visit, the participant having an NRS score of ≥5 for the worst endometriosis related pain during the past menstrual cycle and at randomization, the participant having a mean daily NRS score of ≥4 for the worst endometriosis related pain during each run-in menstrual cycle.
Exclusion Criteria:
* History of no relief of endometriosis related pain after any medical therapy or surgery. However, history of partial pain relief, discontinuation due to side effects are not exclusionary.
* Known bone diseases (e.g. osteoporosis, Paget's disease and osteomalacia) affecting bone resorption or bone formation markers.
* Any significant abnormal findings of heart examinations before randomization.
* History of mental illness including occurrence of acute psychosis, bipolar disorders and schizophrenia (except for well-controlled anxiety and/or depression with no changes to interventions for 6 months prior to start of run-in)
* History of impulse control disorders including pathological gambling, compulsive buying, hypersexuality, and binge eating or being identified with potential impulse control disorder by the questionnaire for impulsive-compulsive disorders (a score ≥2 for any sub-questions of Question 3 or a score ≥1 for any sub-questions of Question 4) prior to randomization.
* History of orthostatic hypotension or recurrent syncope.
* Pre-menopausal females aged ≥18 years at time of signing informed consent(s) with regular menstrual cycles.
* Body mass index (BMI) of 18-42 kg/m2 (both inclusive) at screening.
* Initial confirmation of endometriosis by laparoscopy or laparotomy within the last 10 years before the run-in visit or visualization of persistent endometrioma by repeat ultrasound.
* Transvaginal ultrasound documenting a uterus with no clinically significant abnormalities and presence of at least one ovary with no clinically significant abnormalities (with the exception of endometrioma) at the run-in visit.
* Eligible participants experienced moderate to severe endometriosis-related pain, which was defined as at the run-in visit, the participant having an NRS score of ≥5 for the worst endometriosis related pain during the past menstrual cycle and at randomization, the participant having a mean daily NRS score of ≥4 for the worst endometriosis related pain during each run-in menstrual cycle.
Exclusion Criteria:
* History of no relief of endometriosis related pain after any medical therapy or surgery. However, history of partial pain relief, discontinuation due to side effects are not exclusionary.
* Known bone diseases (e.g. osteoporosis, Paget's disease and osteomalacia) affecting bone resorption or bone formation markers.
* Any significant abnormal findings of heart examinations before randomization.
* History of mental illness including occurrence of acute psychosis, bipolar disorders and schizophrenia (except for well-controlled anxiety and/or depression with no changes to interventions for 6 months prior to start of run-in)
* History of impulse control disorders including pathological gambling, compulsive buying, hypersexuality, and binge eating or being identified with potential impulse control disorder by the questionnaire for impulsive-compulsive disorders (a score ≥2 for any sub-questions of Question 3 or a score ≥1 for any sub-questions of Question 4) prior to randomization.
* History of orthostatic hypotension or recurrent syncope.
Inclusion Criteria
Inclusion Criteria:
* Pre-menopausal females aged ≥18 years at time of signing informed consent(s) with regular menstrual cycles.
* Body mass index (BMI) of 18-42 kg/m2 (both inclusive) at screening.
* Initial confirmation of endometriosis by laparoscopy or laparotomy within the last 10 years before the run-in visit or visualization of persistent endometrioma by repeat ultrasound.
* Transvaginal ultrasound documenting a uterus with no clinically significant abnormalities and presence of at least one ovary with no clinically significant abnormalities (with the exception of endometrioma) at the run-in visit.
* Eligible participants experienced moderate to severe endometriosis-related pain, which was defined as at the run-in visit, the participant having an NRS score of ≥5 for the worst endometriosis related pain during the past menstrual cycle and at randomization, the participant having a mean daily NRS score of ≥4 for the worst endometriosis related pain during each run-in menstrual cycle.
* Pre-menopausal females aged ≥18 years at time of signing informed consent(s) with regular menstrual cycles.
* Body mass index (BMI) of 18-42 kg/m2 (both inclusive) at screening.
* Initial confirmation of endometriosis by laparoscopy or laparotomy within the last 10 years before the run-in visit or visualization of persistent endometrioma by repeat ultrasound.
* Transvaginal ultrasound documenting a uterus with no clinically significant abnormalities and presence of at least one ovary with no clinically significant abnormalities (with the exception of endometrioma) at the run-in visit.
* Eligible participants experienced moderate to severe endometriosis-related pain, which was defined as at the run-in visit, the participant having an NRS score of ≥5 for the worst endometriosis related pain during the past menstrual cycle and at randomization, the participant having a mean daily NRS score of ≥4 for the worst endometriosis related pain during each run-in menstrual cycle.
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03692403
Org Class
Industry
Org Full Name
Ferring Pharmaceuticals
Org Study Id
000165
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase 2 Trial Assessing the Efficacy, Safety and Dose-response of Quinagolide Extended-release Vaginal Rings Administered Sequentially for 4 Menstrual Cycles in Women With Moderate to Severe Endometriosis-related Pain
Primary Outcomes
Outcome Description
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Changes from baseline to cycle 4.
Changes from baseline to cycle 4.
Outcome Measure
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Secondary Outcomes
Outcome Description
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Days with menstrual bleeding (dysmenorrhea). No menstrual bleeding (non-menstrual pelvic pain) Changes from baseline to cycle 4
Days with menstrual bleeding (dysmenorrhea). No menstrual bleeding (non-menstrual pelvic pain) Changes from baseline to cycle 4
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain on Days With Menstrual Bleeding and for the Worst Endometriosis-related Pain on Days With no Menstrual Bleeding
Outcome Description
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Changes over 4 menstrual cycles
Changes over 4 menstrual cycles
Outcome Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.
Outcome Description
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Changes over 4 menstrual cycles
Changes over 4 menstrual cycles
Outcome Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea.
Outcome Description
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Changes over 4 menstrual cycles
Changes over 4 menstrual cycles
Outcome Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain.
Outcome Description
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Changes over 4 menstrual cycles.
Changes over 4 menstrual cycles.
Outcome Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse.
Outcome Description
The participants recorded daily if they had sexual intercourse, in an e-diary. For the days when participants did not have intercourse, the participant recorded if the reason for not having intercourse was because they expected pain: "Yes" (I did not have intercourse this day, because I expected pain) or "No" (I did not have intercourse this day, but this was not because I expected pain). The numbers represent the cumulative number of days with no intercourse, summed across all participants.
In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.
In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.
Outcome Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Frequency of Avoiding Sexual Intercourse Due to Expected Pain
Outcome Description
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Changes over 4 menstrual cycles.
Changes over 4 menstrual cycles.
Outcome Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function.
Outcome Description
Assessed weekly by participants in an e-Diary. EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement.
Changes over 4 menstrual cycles.
Changes over 4 menstrual cycles.
Outcome Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain.
Outcome Description
The participants recorded daily if they had any vaginal bleeding during the past 24 hours, in an e-diary. Of the participants who had a bleeding, the participant recorded if this was menstrual bleeding: "Yes" (I had a vaginal bleeding that was menstrual bleeding) or "No" (I had a vaginal bleeding that was not menstrual bleeding). The numbers represent the cumulative number of days with vaginal bleeding, summed across all participants.
In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.
In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.
Outcome Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period
Outcome Description
The participants recorded daily if they had any vaginal bleeding during the past 24 hours, in an e-diary. Of the participants who had a bleeding, the participant recorded the assessed bleeding volume as either spotting (tiny amount of blood on underwear or panty liners), light bleeding (requiring 1-3 sanitary pads or tampons per day), moderate bleeding (requiring 4-6 sanitary pads or tampons per day), or heavy bleeding (requiring more than 6 sanitary pads or tampons per day). The numbers represent the cumulative number of days with vaginal bleeding, summed across all participants.
In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.
In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.
Outcome Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Changes in Vaginal Bleeding Pattern.
Outcome Description
Assessed daily by participants in an e-Diary
Outcome Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Percentage of Days With Mild and/or Strong Rescue Analgesics Used
Outcome Description
Assessed daily by participants in an e-Diary
Outcome Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Outcome Description
Assessed as ≥30%, ≥50% and ≥70% reduction from the baseline in mean daily NRS score for the worst endometriosis-related pain, dysmenorrhea and non-menstrual pelvic pain and for the worst endometriosis-related pain impact
Outcome Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Responder Rate
Outcome Description
Assessed by the Biberoglu and Behrman (B\&B) scale which is a 4-point scale with 0=none and 3=severe.
The scores are the mean individual scores.
The B\&B scale consists of two parts. The first part of the B\&B scale evaluates symptoms of endometriosis (i.e. pain). There are 3 subscales: pelvic pain(A, 0=none and 3=severe), dysmenorrhea (B, 0=none and 3=severe), and dyspareunia(C, 0=none and 3=severe). The total pelvic pain score is the sum of the three scores, i.e. A+B+C, which can range from 0 to 9. The second part of the B\&B scale evaluates signs of endometriosis. There are 2 subscales pelvic tenderness (D, 0=none and 3=severe) and induration (E, 0=none and 3=severe) based on findings from a pelvic examination. The total physical pain score is the sum of the two scores, i.e. D+E, which can range from 0 to 6. The total symptom and sign severity score is the sum of all five scores, i.e. A+B+C+D+E, which can range from 0 to 15.
The values are the change from baseline to cycle 4.
The scores are the mean individual scores.
The B\&B scale consists of two parts. The first part of the B\&B scale evaluates symptoms of endometriosis (i.e. pain). There are 3 subscales: pelvic pain(A, 0=none and 3=severe), dysmenorrhea (B, 0=none and 3=severe), and dyspareunia(C, 0=none and 3=severe). The total pelvic pain score is the sum of the three scores, i.e. A+B+C, which can range from 0 to 9. The second part of the B\&B scale evaluates signs of endometriosis. There are 2 subscales pelvic tenderness (D, 0=none and 3=severe) and induration (E, 0=none and 3=severe) based on findings from a pelvic examination. The total physical pain score is the sum of the two scores, i.e. D+E, which can range from 0 to 6. The total symptom and sign severity score is the sum of all five scores, i.e. A+B+C+D+E, which can range from 0 to 15.
The values are the change from baseline to cycle 4.
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Changes in the Mean Individual and Total Symptom and Sign Severity Scores
Outcome Description
Assessed by the EHP-30 quality-of-life questionnaire completed by participants. Score ranges from 0-100 with lower score denoting improvement.
Outcome Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Changes in the Endometriosis Health Profile-30 (EHP-30) Scores
Outcome Description
Assessed by the PGIS scale completed by participants. PGIS is a 6-point scale depicting a participant's rating of their current conditions from "good" to "bad".
It ranges from 0 (none) to 5 (very severe).
It ranges from 0 (none) to 5 (very severe).
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Changes in Patient Global Impression of Severity (PGIS) Scores
Outcome Description
Assessed by the PGIC scale completed by participants. PGIC is a 7-point scale depicting a patient's rating of their overall improvement from "good" to "bad".
Outcome Time Frame
At cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Patient Global Impression of Change (PGIC) Scores
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
Within 5 days after first ring insertion and at around 1 month, 3 months, 3.5 months and 4 months after baseline (each cycle is approximately 28 days)
Outcome Measure
Plasma Concentration of Quinagolide and Metabolites
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)
Outcome Measure
Serum Levels of Mid-luteal Phase Progesterone
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)
Outcome Measure
Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml)
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)
Outcome Measure
Serum Levels of Estradiol
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)
Outcome Measure
Serum Levels of Prolactin
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)
Outcome Measure
Serum Levels of Thyrotropin (TSH)
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)
Outcome Measure
Serum Levels of Insulin-like Growth Factor-1 (IGF-1)
Outcome Description
Assessed by blood samples collection. Changes from baseline to cycle 4
Outcome Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Changes in Bone Turnover Markers, Determined by Bone Resorption Marker Serum C-terminal Crosslinking Telopeptide of Type 1 Collagen (s-CTx)
Outcome Description
Assessed by blood samples collection. Changes from baseline to cycle 4
Outcome Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Changes in Bone Turnover Markers, Determined by Bone Formation Marker Serum Procollagen Type I N Propeptide (s-PINP)
Outcome Description
Assessed by 12-lead ECG
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Changes in ECG Parameters Including PR Interval at Cycle 4
Outcome Description
Assessed by 12-lead ECG
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Changes in ECG Parameters Including QRS Duration at Cycle 4
Outcome Description
Assessed by 12-lead ECG
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Changes in ECG Parameters Including QT Interval at Cycle 4
Outcome Description
Assessed by 12-lead ECG
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Changes in ECG Parameters Including QTcF Interval at Cycle 4
Outcome Description
Assessed by echocardiography.
Each echocardiography was to be assessed as normal or abnormal according to American College of Cardiology/American Heart Association guidelines for valvular heart disease. If abnormal, the level of valvular regurgitation and valvular stenosis was specified as mild, moderate or severe and valvular structure was evaluated as well.
Measured at cycle 4.
Each echocardiography was to be assessed as normal or abnormal according to American College of Cardiology/American Heart Association guidelines for valvular heart disease. If abnormal, the level of valvular regurgitation and valvular stenosis was specified as mild, moderate or severe and valvular structure was evaluated as well.
Measured at cycle 4.
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Proportion of Subjects With Abnormal Clinically Significant Echocardiography Findings Indicating Valvular Heart Disease
Outcome Description
Assessed by the questionnaire for impulsive-compulsive disorders completed by participants.
Measured at cycle 4.
Measured at cycle 4.
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Proportion of Subjects Identified With Potential Impulse Control Disorders
Outcome Description
Assessed by an Adverse Events Log completed by the Investigator
Outcome Time Frame
From signing informed consent through study completion, around 8 months
Outcome Measure
Frequency and Intensity of Adverse Events
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Albumin
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Alkaline Phosphatase
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Alanine Aminotransferase
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Aspartate Aminotransferase
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Bicarbonate
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Direct Bilirubin
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Bilirubin
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Calcium
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Cholesterol
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Chloride
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Creatinine
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Gamma Glutamyl Transferase
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Glucose
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Potassium
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Lactate Dehydrogenase
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Phosphate
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Protein
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Sodium
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Urate
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Chemistry Parameters: Urea Nitrogen
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Haematology Parameters: Basophils Absolute
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Haematology Parameters: Basophils
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils Absolute
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Haematology Parameters: Hematocrit
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Haematology Parameters: Hemoglobin
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes Absolute
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Hemoglobin
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular HGB Concentration
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Volume
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes Absolute
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils Absolute
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Haematology Parameters: Platelets
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Haematology Parameters: Erythrocytes
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Changes in Circulating Levels of Clinical Haematology Parameters: Leukocytes
Outcome Description
Assessed by urine sample collection (dip-stick test). Overall Urinalysis Result.
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Urinalysis Parameters (Protein, Glucose, Bilirubin, pH, Nitrite, Ketone, Urobilinogen, Blood, Leukocytes, and Specific Gravity)
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Chemistry Parameters
Outcome Description
Assessed by blood samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months)
Outcome Measure
Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Haematology Parameters
Outcome Description
Assessed by urine samples collection
Outcome Time Frame
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Proportion of Subjects With Markedly Abnormal Changes in Urinalysis Parameters
Outcome Description
Assessed by a questionnaire completed by participants, addressing ring insertion
Outcome Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Outcome Description
Assessed by a questionnaire completed by participants, addressing ring removal.
Outcome Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring
Outcome Description
Assessed by a questionnaire completed by participants, addressing any feeling of the ring while the ring is in the body.
Outcome Time Frame
From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Outcome Measure
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ja Hyun Shin
Investigator Email
jashin@montefiore.org
Investigator Phone