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VMPCO: Vaginal Administration of Metformin in PCOS Patients.

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02026869
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
13
Duration (Months)
15.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Impact of Vaginal Administration of Metformin in Women With PCOS.
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Jun 1, 2013
Anticipated Study Completion Date :
Feb 1, 2014

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ovulation rates [6 months]

      Ovulation rates assessed by transvaginal sonography (TVS) after oral versus vaginal administration of metformin in PCOS women.

    Secondary Outcome Measures

    1. Therapeutic drug level [Over 24 hours after administration.]

      Therapeutic drug levels are measured over 24 hours after oral and vaginal administration of metformin.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Women's Health Hospital Assiut Egypt 71516

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AHMED NASR, Professor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT02026869
    Other Study ID Numbers:
    • Vaginal Metformin- Ahmed Nasr
    First Posted:
    Jan 3, 2014
    Last Update Posted:
    Jan 3, 2014
    Last Verified:
    Jan 1, 2014
    Keywords provided by AHMED NASR, Professor, Assiut University
    Vaginal administration, PCOS, Metformin
    Additional relevant MeSH terms:
    Metformin

    Study Results

    No Results Posted as of Jan 3, 2014