Vaginal Administration of Metformin in PCOS Patients.

Early Phase 1

• Conditions: PCOS
• Interventions: Drug: Metformin

• Registration Number: NCT02026869
• Lead Sponsor: Assiut University

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.

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 Timeline

• Study Start: 2013-01
• Primary Completion: 2013-06
• Status Verified: 2014-01
• Study First Submitted: 2014-01-02
• Study First Submitted QC: 2014-01-02
• Last Update Submitted: 2014-01-02
• Study First Posted: 2014-01-03
• Last Update Posted: 2014-01-03
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Vaginal metformin	Metformin	Metformin 850 mg tablets taken vaginally every 12 hours for 6 months
Oral metformin	Metformin	Metformin 850 mg tablets taken by mouth every 12 hours for 6 months

Primary Outcome Measures

Name	Time	Method
Ovulation rates	6 months	Ovulation rates assessed by transvaginal sonography (TVS) after oral versus vaginal administration of metformin in PCOS women.

Secondary Outcome Measures

Name	Time	Method
Therapeutic drug level	Over 24 hours after administration.	Therapeutic drug levels are measured over 24 hours after oral and vaginal administration of metformin.

Trial Locations

Locations (1)

Women's Health Hospital; 🇪🇬 Assiut, Egypt