- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03819140
Continuous Versus Cyclical OCP Use in PCOS (CCOUP)
Continuous Versus Cyclical OCP Use in PCOS: A Pilot Study
Study Overview
Detailed Description
Those who meet criteria to take part in the study (women between the ages of 16-35 years, diagnosed with PCOS and have findings of hyperandrogenism either by serum testosterone levels above the normal reference range or by their modified Ferriman Gallwey score of >8, and are recommended to start an oral contraceptive pill for therapy) and give consent, will be randomized into either of two oral contraceptive (OCP) treatment groups:
- Ethinyl estradiol 30 mcg-Drospirenone 3 mg (Yasmin): 168 days of active hormone pills (no placebo pills) for 6 months.
- Ethinyl estradiol 30 mcg-Drospirenone 3mg (Yasmin): 21 days of active + 7 days of placebo pills for 6 months
Participants will be given the OCP Yasmin with instructions to take the medication at the same time each day for the length of the study (6 months). On the 4th, 12th and 24th week of therapy (roughly the 1st, 3rd and 6th month), blood work will be drawn and is detailed below.
At 1 month into therapy, (near the end of the 4th week on an OCP) both treatment groups will be expected to get blood work (total and free testosterone, SHBG, estradiol, LH, and FSH levels will be checked). At the time of the blood draw, subjects in the cyclical group should be on placebo/sugar pills and those in the continuous group on active hormone pills.
At 3 months into therapy, participants will come back to the PCOS clinic for routine care follow up and be seen by a Reproductive Endocrinology and Fertility specialist. This visit is considered "standard of care" and not specific to the study. However, during this visit a study investigator will also touch base briefly with the participants to see how they are doing. An online survey (through REDCap) will also be sent to participants that addresses if they have missed any doses of their medication and assess their acne quality of life. In addition, participants will once again get blood work (including total and free testosterone, SHBG, estradiol, LH, FSH, fasting lipid panel, fasting serum glucose, insulin, and HbA1c). As before, the cyclical group should be on placebo/sugar pills at the time of blood draw and the continuous group on active hormone pills.
At 6 months into therapy, participants will come in for a study visit (this is not considered routine care) in which they will have their vitals taken, a physical exam that includes a re-evaluation of their mFG score, and an in-clinic pelvic ultrasound to assess ovarian volume and follicle counts. They will also be emailed a post-study survey through REDCap, that includes a quality of life questionnaire for both acne and hirsutism, and includes questions regarding satisfaction with current therapy and any missed doses of their medication. Lastly, participants will again be expected to get blood work (total and free testosterone, SHBG, estradiol, LH, FSH).
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Heather Huddleston, MD
- Phone Number: (415) 885-3674
- Email: heather.huddleston@ucsf.edu
Study Contact Backup
- Name: Jerrine Morris, MD
- Email: Jerrine.Morris@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94158
- University of California, San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: To be included in this study, participants must be:
- Female, within 15-40 years of age
Diagnosed with Polycystic Ovary Syndrome based on the 2003 Rotterdam Criteria (must meet 2 out of 3 criteria):
- evidence of either biochemical or clinical hyperandrogenism (elevated free and or total testosterone level above the normal reference range for assay, and/or an modified Ferriman-Gallwey hirsutism score >8)
- Oligo- or anovulation
- Polycystic ovary morphology on ultrasound
- Adolescents should be at least 2 years out from menarche (first menstrual period).
- Participants must not be on an oral contraceptive pill (OCP) at the start of the study and or Spironolactone therapy (an anti-androgen medication), but recommended by their physician to start OCP therapy.
Exclusion Criteria:
- Females with Polycystic Ovary Syndrome (PCOS) who do not have either biochemical (elevated total or free testosterone levels) or clinical (modified Ferriman-Gallwey hirsutism score <8) findings of hyperandrogenism will not be included in the study as this is one of the primary outcome measures.
- Females with PCOS who are already on and currently using a form of contraceptive (oral, vaginal ring, or patch)
- Females that are concurrently using or plan to use an anti-androgenic medication such as Spironolactone in the next 6 months.
- Females currently or are planning to obtain permanent hair removal (ex. laser hair removal, electrolysis) in the concurrent 6 months of starting oral contraceptive (OCP) therapy will also be excluded from the study
- Women who are pregnant or have contraindications for starting an OCP, including active smokers, history of clotting disorders, history of deep vein thrombosis or blood clots, neoplasia, vascular disease, migraines, hypertension, or have renal/hepatic disease will be excluded from the study as OCP therapy would not be indicated or approved in this population.
- Females with elevated potassium levels above the normal reference range for age.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Continuous OCP Therapy
Participants randomly assigned to this arm will receive 8 packs of a 21 day oral contraceptive pills (OCP) called Yasmin (3 mg Drospirenone/0.03
mg Ethinyl estradiol) which comes in a formulation of 21 days of active hormone and 7 days of sugar pills.
In this arm, participants will only be expected to take active hormone pills (colored pills) for the 6 months straight without stopping or taking the sugar pills in each pack.
|
Participants in each treatment arm will receive the medication Yasmin.
However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
Active Comparator: Cyclical OCP Therapy
Participants randomly assigned to this arm will receive 6 packs of a 21 day oral contraceptive pill (OCP) called Yasmin (3 mg Drospirenone/0.03
mg Ethinyl estradiol) which has 21 days of active hormone and 7 days of sugar pills.
Participants will take one pill daily for 6 months and be expected to take the sugar pills at the end of each monthly pack prior to starting a new pack.
|
Participants in each treatment arm will receive the medication Yasmin.
However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in biochemical hyperandrogenism
Time Frame: measured at baseline, 1 month, 3 months and 6 months into therapy
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Testosterone level
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measured at baseline, 1 month, 3 months and 6 months into therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in clinical findings of hyperandrogenism - Hirsutism
Time Frame: Baseline and at 6 months into therapy
|
Participants will be examined and scored using the modified Ferriman-Gallwey Hirsutism.
score.
This scoring system is considered the standard scoring system that defines hirsutism (excess male pattern hair growth on the body) quantitatively.
There are 9 body areas measured on a scare of 0-4, with higher values indicative of significant hair growth.
All subscales are combined for a total score, with a minimum score of 0 and max of 36.
A total score of >/=8 is considered diagnostic for hirsutism.
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Baseline and at 6 months into therapy
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Metabolic changes with OCP therapy
Time Frame: Baseline and at 3 months into therapy
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Diabetes risk will be assessed and compared in both treatment arms by measuring HOMA-IR (through insulin and fasting glucose) as well as HbA1c percentage.
|
Baseline and at 3 months into therapy
|
Collaborators and Investigators
Investigators
- Principal Investigator: Heather Huddleston, MD, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-24705
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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