Metformin for Polycystic Ovary Syndrome

University of Virginia, Charlottesville, VA
Polycystic Ovary SyndromeMetformin - Drug
Eligibility
40 - 49
Female
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Study Summary

This trial will compare metformin to oral combined hormonal contraceptives in treating Polycystic Ovary Syndrome in women of later reproductive age, using the Polycystic Ovary Syndrome Questionnaire score as a proxy for patient satisfaction.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase < 1

Similar Trials

Study Objectives

1 Primary · 18 Secondary · Reporting Duration: 6 months after each intervention

Month 6
Glucose
Blood pressure
Body mass index
Calculated free testosterone concentrations
Fasting glucose
Fasting insulin
Framingham risk score
General Anxiety Disorder (GAD)-7 score
HDL cholesterol level
Hemoglobin A1c
Cholesterol
Matsuda index
Sex hormone binding globulin
Short Form (SF)-36 score
Total testosterone concentrations
Triglyceride level
Weight
waist-to-hip ratio
Month 6
Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ) score

Trial Safety

Phase-Based Safety

1 of 3

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.

Trial Design

2 Treatment Groups

Oral combined hormonal contraceptives then metformin
1 of 2
Metformin then oral combined hormonal contraceptives
1 of 2

Active Control

Experimental Treatment

88 Total Participants · 2 Treatment Groups

Primary Treatment: Metformin · No Placebo Group · Phase < 1

Metformin then oral combined hormonal contraceptivesExperimental Group · 2 Interventions: Metformin, Oral combined hormonal contraceptives · Intervention Types: Drug, Drug
Oral combined hormonal contraceptives then metforminActiveComparator Group · 2 Interventions: Metformin, Oral combined hormonal contraceptives · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months after each intervention

Who is running the clinical trial?

University of VirginiaLead Sponsor
706 Previous Clinical Trials
1,468,121 Total Patients Enrolled
26 Trials studying Polycystic Ovary Syndrome
1,116 Patients Enrolled for Polycystic Ovary Syndrome
Su H Kim, MDPrincipal InvestigatorUniversity of Virginia
1 Previous Clinical Trials
144 Total Patients Enrolled
1 Trials studying Polycystic Ovary Syndrome
144 Patients Enrolled for Polycystic Ovary Syndrome

Eligibility Criteria

Age 40 - 49 · Female Participants · 0 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
New Hampshire100.0%
What site did they apply to?
University of Virginia100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%

Frequently Asked Questions

What do Oral combined hormonal contraceptives typically treat?

"Oral combined hormonal contraceptives are frequently employed to treat exercise-induced conditions. Additionally, the drug has therapeutic applications for type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome." - Anonymous Online Contributor

Unverified Answer

What criteria must one fulfill to be eligible for this experiment?

"Successful applicants to this medical trial must be aged between 40 and 49 years old with a diagnosis of polycystic ovaries. A total of 88 participants are being recruited for the experiment." - Anonymous Online Contributor

Unverified Answer

What other explorations have been conducted concerning the efficacy of Oral combined hormonal contraceptives?

"Currently, there are 170 trials being conducted on Oral combined hormonal contraceptives with 43 of them in Phase 3. Rockville, Maryland is one among the 1903 sites hosting these clinical trials; however many other locations exist throughout the country." - Anonymous Online Contributor

Unverified Answer

How many participants has this research recruited thus far?

"Affirmative. According to research posted on clinicaltrials.gov, this medical trial is currently recruiting patients who are able and willing to participate. Originally published on August 23rd 2021 with its last edit occurring October 31st 2022, the study aims to involve 88 people from a single location." - Anonymous Online Contributor

Unverified Answer

Are more participants needed to join this experiment?

"According to clinicaltrials.gov, this trial is still actively seeking patients for participation. It was first launched on August 23rd 2021 and its information has been updated as recently as October 31st 2022." - Anonymous Online Contributor

Unverified Answer

Is the age criteria for this research limited to those under 30 years?

"To be considered for this clinical trial, patients must be between 40 and 49 years old. For those younger than 18 or older than 65, there are 39 trials and 136 trials available respectively." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.