Status:
COMPLETED
Continuous Versus Cyclical OCP Use in PCOS
Lead Sponsor:
University of California, San Francisco
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
15-40 years
Phase:
PHASE4
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-an...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2022
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03819140
Start Date
April 1 2019
End Date
October 16 2022
Last Update
November 14 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94158