Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

not to have received any induction of ovulation in the preceding 3 months before enrollment
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
women with PCOS according to the Rotterdam criteria
age 20-35 years

Exclusion Criterias

contraindications to metformin
prior surgical management of PCOS
contraindications to metformin
prior surgical management of PCOS

Summary

Conditions
PCOS
Type
Interventional
Phase
Early Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Factorial Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 20 years and 35 years
Gender
Only females

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 facto...

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.

Inclusion Criterias

not to have received any induction of ovulation in the preceding 3 months before enrollment
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
women with PCOS according to the Rotterdam criteria
age 20-35 years

Exclusion Criterias

contraindications to metformin
prior surgical management of PCOS
contraindications to metformin
prior surgical management of PCOS

Locations

Assiut, 71516
Assiut, 71516

Tracking Information

NCT #
NCT02026869
Collaborators
Not Provided
Investigators
  • Principal Investigator: AHMED NASR, MD Professor, Women's Health Hospital, Assiut University, Egypt. Study Director: MAGDY AMIN, MD Associate professor, dept. of Obstetrics & gynecology, Sohag University, Egypt
  • AHMED NASR, MD Professor, Women's Health Hospital, Assiut University, Egypt. Study Director: MAGDY AMIN, MD Associate professor, dept. of Obstetrics & gynecology, Sohag University, Egypt