Vaginal Administration of Metformin in PCOS Patients.

NCT ID: NCT02026869

Last Updated: 2014-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-02-28

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.

Conditions

PCOS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral metformin

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

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

Metformin is taken either orally or vaginally every 12 hours

Vaginal metformin

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

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

Metformin is taken either orally or vaginally every 12 hours

Interventions

Metformin

Metformin is taken either orally or vaginally every 12 hours

Intervention Type: DRUG

Other Intervention Names

Cidophage

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

AHMED NASR

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHMED NASR, MD

Role: PRINCIPAL_INVESTIGATOR

Professor, Women's Health Hospital, Assiut University, Egypt.

MAGDY AMIN, MD

Role: STUDY_DIRECTOR

Associate professor, dept. of Obstetrics & gynecology, Sohag University, Egypt

Locations

Women's Health Hospital

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Other Identifiers

Vaginal Metformin- Ahmed Nasr

Identifier Type: -

Identifier Source: org_study_id