OCP + Metformin for Polycystic Ovary Syndrome

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Polycystic Ovary Syndrome
OCP + Metformin - Drug
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

This trial will compare the effect of OCP and metformin on MetS in overweight/obese women with PCOS.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Polycystic Ovary Syndrome

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 6 months

6 months
Change in HDL-C function
Changes in lipid particle size and number
Changes in quality of life parameters in all 3 arms as assessed by PCOSQ
Changes in serum adipokines in the 3 arms
Changes in serum apoliproteins
Changes in serum markers of inflammation and free fatty acids.
Changes in total and visceral body fat distribution in the 3 arms
Prevalence of metabolic syndrome after randomizing to low dose OCP, metformin or OCP+metformin for 6 months.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Polycystic Ovary Syndrome

Trial Design

3 Treatment Groups

OCP + Placebo
1 of 3
Metformin + Placebo
1 of 3
OCP + Metformin
1 of 3
Active Control
Experimental Treatment

240 Total Participants · 3 Treatment Groups

Primary Treatment: OCP + Metformin · Has Placebo Group · Phase 3

OCP + Metformin
Drug
Experimental Group · 1 Intervention: OCP + Metformin · Intervention Types: Drug
OCP + Placebo
Drug
ActiveComparator Group · 1 Intervention: OCP + Placebo · Intervention Types: Drug
Metformin + Placebo
Drug
ActiveComparator Group · 1 Intervention: Metformin + Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,416 Previous Clinical Trials
24,557,227 Total Patients Enrolled
5 Trials studying Polycystic Ovary Syndrome
234 Patients Enrolled for Polycystic Ovary Syndrome
Milton S. Hershey Medical CenterOTHER
455 Previous Clinical Trials
2,784,046 Total Patients Enrolled
6 Trials studying Polycystic Ovary Syndrome
601 Patients Enrolled for Polycystic Ovary Syndrome
Anuja DokrasLead Sponsor
Anuja Dokras, MD2.919 ReviewsPrincipal Investigator - University of Pennsylvania
University of Pennsylvania
5Patient Review
Dr. Dokras is an excellent physician who made me feel comfortable and confident throughout my pregnancy journey. I would highly recommend her to anyone, especially those with PCOS.

Eligibility Criteria

Age 18 - 65 · Female Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have an elevated serum testosterone level or hirsutism, based on a Ferriman Gallwey score > 8 (note: > 2 for women of Asian descent).
You have had 8 or fewer periods per year for at least 3 years.
You are in good general health.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: October 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Ohio50.0%
Washington50.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%