Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate
ss
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
1 other identifier
interventional
90
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2015
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 6, 2016
CompletedFirst Posted
Study publicly available on registry
May 10, 2016
CompletedAugust 18, 2020
August 1, 2020
10 months
May 6, 2016
August 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The change of Doppler resistance index after the treatment
10 days
Study Arms (3)
preparation F12 sildenafil in-situ gel group
EXPERIMENTALwomen 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 F2 sildenafil in-situ gel group
ACTIVE COMPARATORwomen 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
placebo gel group
PLACEBO COMPARATORwomen 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
Interventions
in situ vaginal gel
in situ vaginal gel
Eligibility Criteria
You may qualify if:
- women with polycystic ovaries
You may not qualify if:
- women with other causes of infertility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 27783532DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
May 6, 2016
First Posted
May 10, 2016
Study Start
January 1, 2015
Primary Completion
November 1, 2015
Study Completion
December 1, 2015
Last Updated
August 18, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share