Vaginal Administration of Metformin in PCOS Patients.

PCOS Clinical Trial

— VMPCO  

Official title:

Impact of Vaginal Administration of Metformin in Women With PCOS.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02026869
• Other study ID #: Vaginal Metformin- Ahmed Nasr
• Status: Active, not recruiting
• Phase: Phase 0
• First received: January 2, 2014
• Last updated: January 2, 2014
• Start date: January 2013
• Est. completion date: February 2014

Study information

• Verified date: January 2014
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• PCOS

Intervention

Drug:
• Metformin
Metformin is taken either orally or vaginally every 12 hours

Locations

Country	Name	City	State
Egypt	Women's Health Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovulation rates	Ovulation rates assessed by transvaginal sonography (TVS) after oral versus vaginal administration of metformin in PCOS women.	6 months	No
Secondary	Therapeutic drug level	Therapeutic drug levels are measured over 24 hours after oral and vaginal administration of metformin.	Over 24 hours after administration.	No