Vaginal Administration of Metformin in PCOS Patients.

Impact of Vaginal Administration of Metformin in Women With PCOS.

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02026869

Acronym

VMPCO

Enrollment

200

Registered

2014-01-03

Start date

2013-01-31

Completion date

2014-02-28

Last updated

2014-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCOS

Keywords

Vaginal administration, PCOS, Metformin

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.

Interventions

DRUGMetformin

Metformin is taken either orally or vaginally every 12 hours

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 35 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Ovulation rates	6 months	Ovulation rates assessed by transvaginal sonography (TVS) after oral versus vaginal administration of metformin in PCOS women.

Secondary

Measure	Time frame	Description
Therapeutic drug level	Over 24 hours after administration.	Therapeutic drug levels are measured over 24 hours after oral and vaginal administration of metformin.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026