Vaginal Administration of Metformin in PCOS Patients. (VMPCO)

January 2, 2014 updated by: AHMED NASR, Assiut University

Impact of Vaginal Administration of Metformin in Women With PCOS.

Polycystic ovary syndrome is a common cause of irregular periods, poor ovulation and delay in achieving pregnancy. Certain drugs may help improve ovarian activity in such women as metformin. Oral administration of metformin is accompanied by undesirable side effects. The vagina proved to be a good alternative to the oral route for other drugs. Using metformin through the vagina and avoidance of such side effects, while maintaining its effectiveness, would help women to better tolerate this drug.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

PCOS is the most common of all female endocrinopathies affecting 7-10% of women. A variety of drugs have been used to help improve follicular dynamics in PCOS patients. Metformin, an insulin sensitizer long known for its antidiabetic properties, has been used in PCOS patients. One of the major factors affecting compliance are the gastrointestinal side effects associated with oral administration of metformin. Knowing that the vagina is a good absorptive surface for many drugs, it is postulated that vaginal administration of metformin could be a good alternative to the oral route, if it proves effective. Both pharmacokinetic and clinical evidences of efficacy are traced for the vaginal route of administration.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71516
        • Women's Health Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women with PCOS according to the Rotterdam criteria
  • age 20-35 years
  • not to have received any induction of ovulation in the preceding 3 months before enrollment

Exclusion Criteria:

  • contraindications to metformin
  • prior surgical management of PCOS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Oral metformin
Metformin 850 mg tablets taken by mouth every 12 hours for 6 months
Drug: Metformin
Metformin is taken either orally or vaginally every 12 hours
Other Names:
  • Cidophage
ACTIVE_COMPARATOR: Vaginal metformin
Metformin 850 mg tablets taken vaginally every 12 hours for 6 months
Drug: Metformin
Metformin is taken either orally or vaginally every 12 hours
Other Names:
  • Cidophage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovulation rates
Time Frame: 6 months
Ovulation rates assessed by transvaginal sonography (TVS) after oral versus vaginal administration of metformin in PCOS women.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic drug level
Time Frame: Over 24 hours after administration.
Therapeutic drug levels are measured over 24 hours after oral and vaginal administration of metformin.
Over 24 hours after administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: AHMED NASR, MD, Professor, Women's Health Hospital, Assiut University, Egypt.
  • Study Director: MAGDY AMIN, MD, Associate professor, dept. of Obstetrics & gynecology, Sohag University, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ANTICIPATED)

February 1, 2014

Study Registration Dates

First Submitted

January 2, 2014

First Submitted That Met QC Criteria

January 2, 2014

First Posted (ESTIMATE)

January 3, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 3, 2014

Last Update Submitted That Met QC Criteria

January 2, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vaginal Metformin- Ahmed Nasr

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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