Vaginal Administration of Metformin in PCOS Patients. (VMPCO)

Assiut University

Status and phase: Unknown; Early Phase 1

Conditions: PCOS

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02026869

Vaginal Metformin- Ahmed Nasr

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Oral metformin

Active Comparator group

Description:

Metformin 850 mg tablets taken by mouth every 12 hours for 6 months

Treatment:

Drug: Metformin

Vaginal metformin

Active Comparator group

Description:

Metformin 850 mg tablets taken vaginally every 12 hours for 6 months

Treatment:

Drug: Metformin