Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate

NCT ID: NCT02766725

Last Updated: 2020-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

preparation F12 sildenafil in situ gel

Intervention Type DRUG

in situ vaginal gel

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

Group Type ACTIVE_COMPARATOR

preparation F2 sildenafil in situ gel

Intervention Type DRUG

in situ vaginal gel

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

Group Type PLACEBO_COMPARATOR

placebo gel

Intervention Type DRUG

vaginal gel

Interventions

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preparation F12 sildenafil in situ gel

in situ vaginal gel

Intervention Type DRUG

preparation F2 sildenafil in situ gel

in situ vaginal gel

Intervention Type DRUG

placebo gel

vaginal gel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* women with polycystic ovaries

Exclusion Criteria

* women with other causes of infertility
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Soliman GM, Fetih G, Abbas AM. Thermosensitive bioadhesive gels for the vaginal delivery of sildenafil citrate: in vitro characterization and clinical evaluation in women using clomiphene citrate for induction of ovulation. Drug Dev Ind Pharm. 2017 Mar;43(3):399-408. doi: 10.1080/03639045.2016.1254239. Epub 2016 Nov 14.

Reference Type DERIVED
PMID: 27783532 (View on PubMed)

Other Identifiers

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INSITU

Identifier Type: -

Identifier Source: org_study_id

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