Vaginal Administration of Metformin in PCOS Patients.
Last updated on April 2022Recruitment
- Recruitment Status
- Unknown status
Inclusion Criteria
- women with PCOS according to the Rotterdam criteria
- not to have received any induction of ovulation in the preceding 3 months before enrollment
- age 20-35 years
- women with PCOS according to the Rotterdam criteria
- not to have received any induction of ovulation in the preceding 3 months before enrollment
- age 20-35 years
Exclusion Criteria
- 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 Criteria
- women with PCOS according to the Rotterdam criteria
- not to have received any induction of ovulation in the preceding 3 months before enrollment
- age 20-35 years
- women with PCOS according to the Rotterdam criteria
- not to have received any induction of ovulation in the preceding 3 months before enrollment
- age 20-35 years
Exclusion Criteria
- contraindications to metformin
- prior surgical management of PCOS
- contraindications to metformin
- prior surgical management of PCOS
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
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