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

A

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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