Continuous Versus Cyclical OCP Use in PCOS

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Drospirenone and ethinyl estradiol combination; Ethinyl Estradiol

Criteria

Inclusion Criteria: To be included in this study, participants must be:

1. Female, within 15-40 years of age

2. Diagnosed with Polycystic Ovary Syndrome based on the 2003 Rotterdam Criteria (must meet 2 out of 3 criteria):

1. 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)

2. Oligo- or anovulation

3. Polycystic ovary morphology on ultrasound

3. Adolescents should be at least 2 years out from menarche (first menstrual period).

4. 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:

1. 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.

2. Females with PCOS who are already on and currently using a form of contraceptive (oral, vaginal ring, or patch)

3. Females that are concurrently using or plan to use an anti-androgenic medication such as Spironolactone in the next 6 months.

4. 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

5. 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.

6. Females with elevated potassium levels above the normal reference range for age.