Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate
Phase 2
Completed
- Conditions
- Infertility
- Interventions
- Registration Number
- NCT02766725
- Lead Sponsor
- Assiut University
- Brief Summary
The aim of this study was to develop and characterize in situ thermosensitive gels for the vaginal administration of sildenafil as a potential treatment of the endometrial thinning that occurs as a result of the use of clomiphene citrate in induction of ovulation in women with World Health Organization type II EU gonadotrophic anovulation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 90
Inclusion Criteria
- women with polycystic ovaries
Exclusion Criteria
- women with other causes of infertility
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description preparation F12 sildenafil in-situ gel group preparation F12 sildenafil in situ gel women received clomiphene citrate 150 mg/d in three divided doses 50 mg each starting from day 2 of menstruation for 5 days + preparation F12 sildenafil gel vaginally from day 5 to day 12 of menstrual cycle twice daily by a specific applicator (25 mg) per dose preparation F2 sildenafil in-situ gel group preparation F2 sildenafil in situ gel women received clomiphene citrate 150 mg/d in three divided doses 50 mg each starting from day 2 of menstruation for 5 days + preparation F2 sildenafil gel vaginally from day 5 to day 12 of menstrual cycle twice daily by a specific applicator (25 mg) per dose placebo gel group placebo gel women received clomiphene citrate 150 mg/d in three divided doses 50 mg each starting from day 2 of menstruation for 5 days + placebo gel vaginally from day 5 to day 12 of menstrual cycle twice daily by a specific applicator
- Primary Outcome Measures
Name Time Method The change of Doppler resistance index after the treatment 10 days
- Secondary Outcome Measures
Name Time Method