Relative Desirability of Metformin vs. Birth Control Pill in Treating PCOS in Women of Later Reproductive Age

NCT03905941 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: 21649
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine the relative desirability of metformin vs. oral combined hormonal contraceptives (OCs) in treating Polycystic Ovary Syndrome (PCOS) in women of later reproductive age. Polycystic Ovary Syndrome Questionnaire (PCOSQ) score will be used as a proxy for patient satisfaction. In light of their respective effects on the classic and metabolic facets of PCOS, metformin will provide non-inferior patient satisfaction compared to OCs in later reproductive age women with PCOS.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (2)

• Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ) score

  It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function.

  baseline

• Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ) score

  It is a 7-point scale questionnaire assessing health-related quality of life specific to PCOS in 5 different domains, with "7" representing optimal function and "1" representing poorest function.

  6 months after each intervention.

Secondary Outcomes (36)

• Short Form (SF)-36 score

  baseline

• Short Form (SF)-36 score

  6 months after each intervention

• General Anxiety Disorder (GAD)-7 score

  baseline

• General Anxiety Disorder (GAD)-7 score

  6 months after each intervention

• Total testosterone concentrations

  baseline

Study Arms (2)

Metformin then oral combined hormonal contraceptives

EXPERIMENTAL

Subjects will take metformin 2000 mg/day for the first 6 months, followed by 6 months of oral combined hormonal contraceptive (OCs) with a combination of ethinyl estradiol 20 mcg/norethindrone acetate 1 mg.

Drug: Metformin; Drug: Oral combined hormonal contraceptives

Oral combined hormonal contraceptives then metformin

ACTIVE COMPARATOR

Subjects will take oral combined hormonal contraceptive (OCs) with a combination of ethinyl estradiol 20 mcg/norethindrone acetate 1 mg for the first 6 months, followed by 6 months of metformin 2000 mg/day.

Drug: Metformin; Drug: Oral combined hormonal contraceptives

Interventions

Metformin DRUG

Metformin 2000 mg/day will be used in this study. Metformin is a antihyperglycemic agent that is used as a first line medical therapy to treat type 2 diabetes mellitus. It is also used to prevent progression of impaired glucose tolerance. It decrease hepatic glucose production and increase insulin sensitivity.

Metformin then oral combined hormonal contraceptives; Oral combined hormonal contraceptives then metformin

Oral combined hormonal contraceptives DRUG

Oral combined hormonal contraceptive (OCs) with a combination of ethinyl estradiol 20 mcg/norethindrone acetate 1 mg will be used in this study. OCs are normally used to prevent pregnancy by suppressing ovulation and to prevent endometrial hyperplasia by inducing regular "withdrawal" bleeding. OCs help control both clinical and biochemical hyperandrogenism in PCOS and are considered first line medical therapy until the age of menopause.

Metformin then oral combined hormonal contraceptives; Oral combined hormonal contraceptives then metformin

Eligibility Criteria

• Age: 40 Years - 49 Years
• Gender Eligibility Details: This study is about PCOS, therefore only females will be studied.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women with PCOS aged 40-49 years. Subject is considered to have PCOS if she has current or verifiable history of: a) clinical and/or biochemical evidence of hyperandrogenism plus b) oligomenorrhea or irregular menstruation (substantially inconsistent menstrual cycle length). Subjects with fewer than 10 menses/year or average menstrual cycle length \>35 days are allowed to participate if they have a compelling past history of oligomenorrhea (average menstrual cycle length \>45 days or fewer than 9 menses/year) or irregular menstruation.

You may not qualify if:

• Subjects must be willing and able to provide written informed consent.
• Willingness to strictly avoid pregnancy (using non-hormonal methods) during the time of the study
• Willingness and ability to comply with scheduled visits and study procedures
• Postmenopausal status (i.e., absence of periods for previous year plus elevated follicle stimulating hormone \[FSH\] level)
• Biochemical evidence for perimenopause as defined by an anti-Mullerian hormone \<0.5 ng/mL. As an alternative, cycle day 3 FSH \> 9 IU/L (with concomitant estradiol level \>80 pg/mL), if this testing is available, will serve as evidence of perimenopause status. NOTE: If FSH \>9 IU/L on screening (but it is not cycle day 3), FSH and estradiol will be repeated on cycle day 3
• History of hysterectomy and/or bilateral oophorectomy
• BMI ≥ 40 kg/m2
• Inability to comprehend what will be done during the study or why it will be done.
• Being a study of older women with PCOS, children and men will be excluded.
• Pregnancy or lactation within the past 6 months. Subjects with a positive pregnancy test will be informed of the result by the screening physician.
• Prisoners.
• History of (or clinical evidence for) Cushing's syndrome or adrenal insufficiency.
• History of congenital adrenal hyperplasia or 17-hydroxyprogesterone (17-OHP) \>200 ng/dL, which suggest the possibility of congenital adrenal hyperplasia. 17-OHP will be collected during follicular phase. NOTE: if a 17-OHP \>200 ng/dL and is confirmed on repeat testing, an ACTH-stimulated 17-OHP \<1000 ng/dL will be required for study participation.
• Total testosterone \>150 ng/dL, which suggests the possibility of virilizing neoplasm.
• DHEA-S greater than 1.5 times the upper limit of normal range (mild elevations may be seen in PCOS, so elevations \< 1.5 times the upper limit of normal will be accepted in these groups).

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22901, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Christine Burt Solorzano, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: This is a randomized, controlled, double blinded, controlled, crossover study.

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 8, 2019
• Study Start: August 23, 2021
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (1)