Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate
NCT ID: NCT02766725
Last Updated: 2020-08-18
Study Results
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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COMPLETED
PHASE2/PHASE3
90 participants
INTERVENTIONAL
2015-01-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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
preparation F12 sildenafil in situ gel
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
preparation F2 sildenafil in situ gel
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
placebo gel
vaginal gel
Interventions
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preparation F12 sildenafil in situ gel
in situ vaginal gel
preparation F2 sildenafil in situ gel
in situ vaginal gel
placebo gel
vaginal gel
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
40 Years
FEMALE
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Ahmed Mohamed Abbas
Dr
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.
Other Identifiers
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INSITU
Identifier Type: -
Identifier Source: org_study_id
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