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NCT02766725 Clinical Trial

Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate

Infertility Clinical Trial

— ss  

Official title:
Development and Clinical Evaluation of Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate on the Endometrium of Women Use Clomiphene Citrate for Induction of Ovulation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02766725
Other study ID # INSITU
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date January 2015
Est. completion date December 2015

Study information
Verified date August 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date December 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- women with polycystic ovaries

Exclusion Criteria:

- women with other causes of infertility

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• preparation F12 sildenafil in situ gel
in situ vaginal gel
• preparation F2 sildenafil in situ gel
in situ vaginal gel
• placebo gel
vaginal gel

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Outcome
Type Measure Description Time frame Safety issue
Primary The change of Doppler resistance index after the treatment 10 days
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