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Sildenafil Vaginal Gel Co-treatment With Clomiphene Citrate in Infertile Women With Thin Endometrium

NCT02710981 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-05-05

Study results available
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Summary

This is a prospective self controlled clinical trial. Women with clomiphene Citrate failure, and thin endometrium were recruited (N = 42). In their 6th (Clomiphene citrate only) cycle, women continued on Clomiphene citrate 100 mg/ day for 5 days, and had sonographic measurement of their endometrial thickness , and Doppler evaluation of their uterine arteries on the day of HCG administration. In 7th cycle, women (N = 36) were given usual dose of Clomiphene citrate supplemented with sildenafil vagina gel (5 gm, containing 50 mg sildenafil) twice daily from cycle day 8 till the day of HCG injection. Endometrial thickness and uterine artery Doppler were measured on the day of HCG administration.

Conditions

  • Anovulation

Interventions

DRUG

clomiphene citrate

Clomiphene citrate only arm: Patients received Clomiphene citrate induction ( (in a dose of 100 mg/ day in two divided doses starting from day 3 of the cycle for 5 days) for the 6th cycle. A gel base, without medicament (vehicle only), was applied vaginally in a dose of 5 gm twice per day, from cycle day 8 to the day of HCG injection. Sonographic assessment of endometrial thickness together with Uterine artery Doppler evaluation were done in the late proliferative phase ( Day of HCG injection).

DRUG

Sildenafil vaginal gel

In addition to clomiphene citrate treatment as the previous group, women in the second arm were prescribed sildenafil vaginal gel in a dose of 5 g gel applied vaginally twice daily from cycle day 8 to the day of HCG injection. The sildenafil vaginal gel consists of sildenafil acetate as a medicament loaded on an in situ gelling system based on two polymers: Pluronic p-127, and Hydroxy Ethyl Cellulose.The gel was prepared in collaboration with the department of pharmaceutics, faculty of Pharmacy, Assiut University. Sixty grams of gel were prepared in tubes and every patient was given 10 applicators like that used for administration of vaginal antimycotic creams to use them for applying the gel.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Ahmed N. Fetih, M.D. · Assiut University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-01-31
Completion
2016-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02710981 on ClinicalTrials.gov