Back to resultsThermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate (ss)
Primary Purpose
Infertility
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
preparation F12 sildenafil in situ gel
preparation F2 sildenafil in situ gel
placebo gel
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- women with polycystic ovaries
Exclusion Criteria:
- women with other causes of infertility
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
preparation F12 sildenafil in-situ gel group
preparation F2 sildenafil in-situ gel group
placebo gel group
Arm 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
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
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
Outcomes
Primary Outcome Measures
The change of Doppler resistance index after the treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02766725
Brief Title
Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate
Acronym
ss
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
preparation F12 sildenafil in-situ gel group
Arm Type
Experimental
Arm 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
Arm Title
preparation F2 sildenafil in-situ gel group
Arm Type
Active Comparator
Arm 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
Arm Title
placebo gel group
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
preparation F12 sildenafil in situ gel
Intervention Description
in situ vaginal gel
Intervention Type
Drug
Intervention Name(s)
preparation F2 sildenafil in situ gel
Intervention Description
in situ vaginal gel
Intervention Type
Drug
Intervention Name(s)
placebo gel
Intervention Description
vaginal gel
Primary Outcome Measure Information:
Title
The change of Doppler resistance index after the treatment
Time Frame
10 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women with polycystic ovaries
Exclusion Criteria:
women with other causes of infertility
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27783532
Citation
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.
Results Reference
derived
Learn more about this trial
Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate
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