ss: Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT02766725

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: preparation F12 sildenafil in situ gel Drug: preparation F2 sildenafil in situ gel Drug: placebo gel	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: preparation F12 sildenafil in-situ gel group 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	Drug: preparation F12 sildenafil in situ gel in situ vaginal gel
Active Comparator: preparation F2 sildenafil in-situ gel group 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	Drug: preparation F2 sildenafil in situ gel in situ vaginal gel
Placebo Comparator: placebo gel group 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	Drug: placebo gel vaginal gel

Arm

Intervention/Treatment

Experimental: preparation F12 sildenafil in-situ gel group

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

Drug: preparation F12 sildenafil in situ gel

in situ vaginal gel

Active Comparator: preparation F2 sildenafil in-situ gel group

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

Drug: preparation F2 sildenafil in situ gel

in situ vaginal gel

Placebo Comparator: placebo gel group

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

Drug: placebo gel

vaginal gel

Outcome Measures

Primary Outcome Measures

The change of Doppler resistance index after the treatment [10 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

women with polycystic ovaries

Exclusion Criteria:

women with other causes of infertility

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Mohamed Abbas, Dr, Assiut University

ClinicalTrials.gov Identifier:

NCT02766725

Other Study ID Numbers:

INSITU

First Posted:

May 10, 2016

Last Update Posted:

Aug 18, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Sildenafil Citrate

Study Results

No Results Posted as of Aug 18, 2020