This trial is active, not recruiting.

Condition pcos
Treatment metformin
Phase phase 0
Sponsor Assiut University
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Metformin 850 mg tablets taken by mouth every 12 hours for 6 months
metformin Cidophage
Metformin is taken either orally or vaginally every 12 hours
(Active Comparator)
Metformin 850 mg tablets taken vaginally every 12 hours for 6 months
metformin Cidophage
Metformin is taken either orally or vaginally every 12 hours

Primary Outcomes

Ovulation rates
time frame: 6 months

Secondary Outcomes

Therapeutic drug level
time frame: Over 24 hours after administration.

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Assiut University.