Vaginal Administration of Metformin in PCOS Patients.
This trial is active, not recruiting.
|Start date||January 2013|
|End date||June 2013|
|Trial size||200 participants|
|Trial identifier||NCT02026869, Vaginal Metformin- Ahmed Nasr|
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.
|Endpoint classification||efficacy study|
|Intervention model||factorial assignment|
time frame: 6 months
Therapeutic drug level
time frame: Over 24 hours after administration.
Female participants from 20 years up to 35 years old.
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
|Official title||Impact of Vaginal Administration of Metformin in Women With PCOS.|
|Principal investigator||AHMED NASR, MD|
|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.|
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