NCT02663830

Brief Summary

The aim of the study is to evaluate the effect of sildenafil citrate on the pregnancy rate in women undergoing induction of ovulation using clomiphene citrate.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2017

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

January 21, 2016

Last Update Submit

August 13, 2017

Conditions

Anovulatory

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    6 weeks

Secondary Outcomes (4)

  • endometrial thickness

    2 weeks

  • miscarriage rate

    13 weeks

  • ectopic pregnancy rate

    8 weeks

  • Side Effects of Vasodilators

    4 weeks

Study Arms (2)

(Sildenafil & clomiphene citrate group)

EXPERIMENTAL

105 Patients will receive 25 mg sildenafil citrate 6 hourly orally (day 6 to the end of the cycle), and clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation

Drug: Sildenafil & clomiphene citrate

clomiphene only

ACTIVE COMPARATOR

105 patients will receive only clomiphene citrate 100mg/day (day 2 to 6) orally (2 tablets at same time daily).

Drug: clomiphene only

Interventions

Sildenafil & clomiphene citrateDRUG

105 Patients will receive 25 mg sildenafil citrate 6hourly orally (day 6 to the end of the cycle), and clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation

Also known as: seldin and clomid
(Sildenafil & clomiphene citrate group)
clomiphene onlyDRUG

105 Patients will receive clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation

Also known as: clomid
clomiphene only

Eligibility Criteria

Age21 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women age 21-35 years.
  • Anovulatory cycles due to polycystic ovaries syndrome.
  • Non-smokers.
  • Free of major medical illness

You may not qualify if:

  • Women with myoma or adenomyosis
  • Women with congenital uterine anomaly.
  • Chronic use of any medications including non-steroidal anti-inflammatory drugs.
  • Associated cases of infertility other than PCOs (male factor, tubal factor,….).
  • Asherman syndrome.
  • Cases with endometrial hyperplasia.
  • Cases with endometrial polyp

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anovulation

Interventions

Sildenafil CitrateClomiphene

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 21, 2016

First Posted

January 26, 2016

Study Start

January 10, 2016

Primary Completion

January 10, 2017

Study Completion

March 12, 2017

Last Updated

August 16, 2017

Record last verified: 2017-08