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Combination Oral Contraceptive
Continuous OCP Therapy for Polycystic Ovary Syndrome (CCOUP Trial)
Phase 4
Waitlist Available
Led By Heather Huddleston, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female, within 15-40 years of age
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline, 1 month, 3 months and 6 months into therapy
Awards & highlights
CCOUP Trial Summary
This trial looks at whether a continuous 6 month oral contraceptive pill or a traditional 21 day active/7 day placebo pill has any effect on testosterone levels and clinical findings of hyperandrogenism in women with polycystic ovary syndrome.
CCOUP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCCOUP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at baseline, 1 month, 3 months and 6 months into therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline, 1 month, 3 months and 6 months into therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in biochemical hyperandrogenism
Secondary outcome measures
Change in clinical findings of hyperandrogenism - Hirsutism
Metabolic changes with OCP therapy
CCOUP Trial Design
2Treatment groups
Active Control
Group I: Continuous OCP TherapyActive Control1 Intervention
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.
Group II: Cyclical OCP TherapyActive Control1 Intervention
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.
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,496 Previous Clinical Trials
11,933,429 Total Patients Enrolled
6 Trials studying Polycystic Ovary Syndrome
165 Patients Enrolled for Polycystic Ovary Syndrome
Heather Huddleston, MDPrincipal InvestigatorUniversity of California, San Francisco
6 Previous Clinical Trials
8,267 Total Patients Enrolled
4 Trials studying Polycystic Ovary Syndrome
87 Patients Enrolled for Polycystic Ovary Syndrome
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