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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral metformin | Active Comparator | Metformin 850 mg tablets taken by mouth every 12 hours for 6 months |
|
| Vaginal metformin | Active Comparator | Metformin 850 mg tablets taken vaginally every 12 hours for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin is taken either orally or vaginally every 12 hours |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AHMED NASR, MD | Professor, Women's Health Hospital, Assiut University, Egypt. | Principal Investigator |
| MAGDY AMIN, MD | Associate professor, dept. of Obstetrics & gynecology, Sohag University, Egypt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Health Hospital | Asyut | Asyut Governorate | 71516 | Egypt |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |