Vaginal Administration of Metformin in PCOS Patients.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Vaginal Administration of Metformin in Women With PCOS.

Conditions
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PCOS

Intervention / Treatment
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* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral metformin<br>Metformin 850 mg tablets taken by mouth every 12 hours for 6 months | Drug: Metformin<br>* Metformin is taken either orally or vaginally every 12 hours<br>* Other names: Cidophage;|
| Active Comparator: Vaginal metformin<br>Metformin 850 mg tablets taken vaginally every 12 hours for 6 months | Drug: Metformin<br>* Metformin is taken either orally or vaginally every 12 hours<br>* Other names: Cidophage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulation rates | 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 | Therapeutic drug levels are measured over 24 hours after oral and vaginal administration of metformin. | Over 24 hours after administration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal administration, PCOS, Metformin