NCT00703508

Brief Summary

  1. 1.The polycystic ovary syndrome is the major cause of infertility in the United States. Metformin has been shown to increase frequency of ovulations in PCOS, and is used in clinical practice to treat infertility, but some women with PCOS do not respond to metformin treatment.
  2. 2.Knowing that a specific gene predicts the effect of metformin on ovulation would facilitate more efficient and effective treatment of infertility in PCOS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2008

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

April 25, 2017

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

5.2 years

First QC Date

June 20, 2008

Results QC Date

January 5, 2017

Last Update Submit

June 9, 2017

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS

Outcome Measures

Primary Outcomes (2)

  • Number of Responders/Non-responders for Each STK11 rs8111699 Genotype (C/G, C/C, G/G)

    Responders were defined as those that had a doubling of baseline ovulation rate estimated by self-report of menstrual history.

    9 months

  • Ovulation Rate Over Study Duration for STK11 Genotypes CC, CG and GG

    Ovulations were determined by measurement of daily urine pregnanediol-3-glucuronide or weekly progesterone levels over 6-9 months of study duration for each participant. The ovulation rate was calculated as the number of confirmed ovulation events per months of study participation.

    9 months

Secondary Outcomes (1)

  • Determine in Which Genotype(s) Frequency of Ovulation Correlates With Improvement in Reduction in Total Testosterone and Insulin Sensitivity as Measured by the Matsuda Index.

    9 months

Study Arms (1)

Metformin

EXPERIMENTAL

Metformin tablet, 500 mg/tablet, 2 tablets every twelve hours, 9 months duration

Drug: Metformin 500 mg tablet

Interventions

Metformin 500 mg tabletDRUG

Metformin 500 mg tablets; two tablets every 12 hours for 9 months

Also known as: Glucophage
Metformin

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal women between 18-45 years of age and BMI less than 42

You may not qualify if:

  • Diabetes mellitus by fasting glucose or OGTT, or clinically significant pulmonary, cardiac,renal,hepatic,neurologic,psychiatric,infectious,neoplastic and malignant disease (other than non-melanoma skin cancer) -Current use of oral contraceptives; use of fertility drugs within 6 months of study -Current or recent use (within 3 months prior to study entry) of metformin -Documented or suspected recent (within one year)history of drug abuse or alcoholism -Ingestion of any investigational drug within two months prior to study onset.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Of Virginia General Clinical Research Center

Charlottesville, Virginia, 22908, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • Cheang KI, Bhavi Modi, Maria Shulleeta, William S. Evans, Lubna Pal, Jerome F. Strauss and John E. Nestler: Genetic Polymorphisms and Ovulatory Responsiveness to Metformin in Women with Polycystic Ovary Syndrome. Endo Reviews 36 (2): Supplement THR-109, Apr. 2015.

    RESULT

Related Links

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

MetforminTablets

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsDosage FormsPharmaceutical Preparations

Limitations and Caveats

Interpretations of our findings are limited by our small sample size.

Results Point of Contact

Title
Dr. Kai Cheang
Organization
Virginia Commonwealth University
kicheang@vcu.edu
(804) 828-2257

Study Officials

  • John E. Nestler, M.D.

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2008

First Posted

June 23, 2008

Study Start

July 1, 2008

Primary Completion

September 1, 2013

Study Completion

March 1, 2014

Last Updated

June 14, 2017

Results First Posted

April 25, 2017

Record last verified: 2017-06

Locations

US(2)