Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

women with polycystic ovaries

Exclusion criteria

women with other causes of infertility

Treatment and study plan

preparation F12 sildenafil in situ gel

Drug

in situ vaginal gel

preparation F2 sildenafil in situ gel

Drug

in situ vaginal gel

Placebo Gel

Drug

vaginal gel

Primary outcomes

The change of Doppler resistance index after the treatment

Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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

Acronym: ss

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: May 10, 2016
Registry last updated: Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed