Continuous Versus Cyclical OCP Use in PCOS
CCOUP
1 other identifier
interventional
51
1 country
1
Brief Summary
The mainstay treatment for females with Polycystic Ovary Syndrome (PCOS) has long been a combination of an oral contraceptive pill or OCP (containing both estrogen and progestin) along with an anti-androgen medication (such as Spironolactone) to not only prevent chronic anovulation but also suppress elevated testosterone levels and its clinical effects on the body. While there are multiple OCPs available on the market today and several studies that look at different progestins and their anti-androgenicity, not much is known about whether the length of active pills in OCP therapy (3 weeks versus 6 months) has any further benefit in continued suppression of testosterone and subsequently improvement in clinical findings of hyperandrogenism in the PCOS population. In this pilot randomized open label clinical trial, females between the ages of 16 and 35 years diagnosed with PCOS based on the Rotterdam Criteria, and not currently on medical therapy with an OCP will be enrolled in the study and randomized to either a continuous 6 month OCP or cyclical 21 day active OCP therapy. Our aim is to conduct a pilot randomized clinical trial to determine the effect of 6 months of active monophasic OCPs on testosterone levels and cutaneous findings of hyperandrogenism (hirsutism and acne) as compared to a traditional 21 day active/7 day placebo OCP in women with PCOS. These findings will be compared over a 6 month period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2019
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2018
CompletedFirst Posted
Study publicly available on registry
January 28, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2022
CompletedResults Posted
Study results publicly available
November 14, 2025
CompletedNovember 14, 2025
October 1, 2025
3.5 years
November 29, 2018
October 17, 2023
October 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Biochemical Hyperandrogenism From Baseline to 1 Month Post Yasmin Initiation
Positive or negative change in blood serum Total Testosterone value (units: ng/dl) from baseline to 1 month post Yasmin initiation.
measured at baseline and 1 month into therapy
Change in Biochemical Hyperandrogenism From Baseline to 3 Month Post Yasmin Initiation
Positive or negative change in blood serum Total Testosterone value (units: ng/dl) from baseline to 3 month post Yasmin initiation.
measured at baseline and 3 month into therapy
Change in Biochemical Hyperandrogenism From Baseline to 6 Month Post Yasmin Initiation
Positive or negative change in blood serum Total Testosterone value (units: ng/dl) from baseline to 6 month post Yasmin initiation.
measured at baseline and 6 month into therapy
Secondary Outcomes (2)
Change in Clinical Findings of Hyperandrogenism - Hirsutism
Baseline and at 6 months into therapy
Metabolic Changes With OCP Therapy
Baseline and at 3 months into therapy
Study Arms (2)
Continuous OCP Therapy
ACTIVE COMPARATORParticipants 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.
Cyclical OCP Therapy
ACTIVE COMPARATORParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94158, United States
Related Publications (1)
Legro RS, Pauli JG, Kunselman AR, Meadows JW, Kesner JS, Zaino RJ, Demers LM, Gnatuk CL, Dodson WC. Effects of continuous versus cyclical oral contraception: a randomized controlled trial. J Clin Endocrinol Metab. 2008 Feb;93(2):420-9. doi: 10.1210/jc.2007-2287. Epub 2007 Dec 4.
PMID: 18056769BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Heather Huddleston
- Organization
- University of California, San Francisco
Study Officials
- PRINCIPAL INVESTIGATOR
Heather Huddleston, MD
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2018
First Posted
January 28, 2019
Study Start
April 1, 2019
Primary Completion
October 16, 2022
Study Completion
October 16, 2022
Last Updated
November 14, 2025
Results First Posted
November 14, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share