Vaginal Administration of Metformin in PCOS Patients.
Overview[ - collapse ][ - ]
| Purpose | 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 | PCOS |
| Intervention | Drug: Metformin |
| Phase | Phase 0 |
| Sponsor | Assiut University |
| Responsible Party | Assiut University |
| ClinicalTrials.gov Identifier | NCT02026869 |
| First Received | January 2, 2014 |
| Last Updated | January 2, 2014 |
| Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 2, 2014 |
|---|---|
| Last Updated Date | January 2, 2014 |
| Start Date | January 2013 |
| Estimated Primary Completion Date | February 2014 |
| Current Primary Outcome Measures | Ovulation rates [Time Frame: 6 months] [Designated as safety issue: No]Ovulation rates assessed by transvaginal sonography (TVS) after oral versus vaginal administration of metformin in PCOS women. |
| Current Secondary Outcome Measures | Therapeutic drug level [Time Frame: Over 24 hours after administration.] [Designated as safety issue: No]Therapeutic drug levels are measured over 24 hours after oral and vaginal administration of metformin. |
Descriptive Information[ + expand ][ + ]
| Brief Title | Vaginal Administration of Metformin in PCOS Patients. |
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| Official Title | Impact of Vaginal Administration of Metformin in Women With PCOS. |
| 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 Type | Interventional |
| Study Phase | Phase 0 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | PCOS |
| Intervention | Drug: Metformin Metformin is taken either orally or vaginally every 12 hours Other Names: Cidophage |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
|---|---|
| Estimated Enrollment | 200 |
| Estimated Completion Date | February 2014 |
| Estimated Primary Completion Date | June 2013 |
| Eligibility Criteria | 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 |
| Gender | Female |
| Ages | 20 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Egypt |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT02026869 |
|---|---|
| Other Study ID Numbers | Vaginal Metformin- Ahmed Nasr |
| Has Data Monitoring Committee | No |
| Information Provided By | Assiut University |
| Study Sponsor | Assiut University |
| Collaborators | Not Provided |
| 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 |
| Verification Date | January 2014 |
Locations[ + expand ][ + ]
| Women's Health Hospital | Assiut, Egypt, 71516 |
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