NCT02026869

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2013

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

January 3, 2014

Status Verified

January 1, 2014

Enrollment Period

5 months

First QC Date

January 2, 2014

Last Update Submit

January 2, 2014

Conditions

PCOS

Keywords

Vaginal administration, PCOS, Metformin

Outcome Measures

Primary Outcomes (1)

  • Ovulation rates

    Ovulation rates assessed by transvaginal sonography (TVS) after oral versus vaginal administration of metformin in PCOS women.

    6 months

Secondary Outcomes (1)

  • Therapeutic drug level

    Over 24 hours after administration.

Study Arms (2)

Oral metformin

ACTIVE COMPARATOR

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

Drug: Metformin

Vaginal metformin

ACTIVE COMPARATOR

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

Drug: Metformin

Interventions

MetforminDRUG

Metformin is taken either orally or vaginally every 12 hours

Also known as: Cidophage
Oral metforminVaginal metformin

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • contraindications to metformin
  • prior surgical management of PCOS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Health Hospital

Asyut, Asyut Governorate, 71516, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • AHMED NASR, MD

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

    PRINCIPAL INVESTIGATOR

  • MAGDY AMIN, MD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 3, 2014

Study Start

January 1, 2013

Primary Completion

June 1, 2013

Study Completion

February 1, 2014

Last Updated

January 3, 2014

Record last verified: 2014-01

Locations

EG(1)