MedTrace Logo

Continuous Versus Cyclical OCP Use in PCOS

NCT03819140 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-11-14

Study results available
· View outcomes & findings →

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.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

Yasmin

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.

Sponsors & Collaborators

Principal Investigators

  • Heather Huddleston, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2022-10-16
Completion
2022-10-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03819140 on ClinicalTrials.gov