Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate (ss)

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Infertility

Treatments: Drug: preparation F2 sildenafil in situ gel; Drug: preparation F12 sildenafil in situ gel; Drug: placebo gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02766725

INSITU

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women with polycystic ovaries

Exclusion criteria

• women with other causes of infertility

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

preparation F12 sildenafil in-situ gel group

Experimental group

Description:

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

Treatment:

Drug: preparation F12 sildenafil in situ gel

preparation F2 sildenafil in-situ gel group

Active Comparator group

Description:

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

Treatment:

Drug: preparation F2 sildenafil in situ gel

placebo gel group

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo gel