Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02766725

Acronym

Enrollment

Registered

2016-05-10

Start date

2015-01-31

Completion date

2015-12-31

Last updated

2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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.

Interventions

DRUGpreparation F12 sildenafil in situ gel

in situ vaginal gel

DRUGpreparation F2 sildenafil in situ gel

in situ vaginal gel

DRUGplacebo gel

vaginal gel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

Inclusion criteria

* women with polycystic ovaries

Exclusion criteria

* women with other causes of infertility

Design outcomes

Primary

Measure	Time frame
The change of Doppler resistance index after the treatment	10 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026