NCT00123162

Brief Summary

The primary hypothesis is that a 100mg single dose of sildenafil citrate (Viagra) will have a higher improvement rate when compared to placebo in the treatment of moderate to severe primary dysmenorrhea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
1.8 years until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

December 23, 2015

Completed
Last Updated

December 23, 2015

Status Verified

November 1, 2015

Enrollment Period

4.1 years

First QC Date

July 20, 2005

Results QC Date

January 16, 2015

Last Update Submit

November 18, 2015

Conditions

Dysmenorrhea

Keywords

Sildenafil

Outcome Measures

Primary Outcomes (1)

  • The Primary Outcome Was Total Pain Relief Over 4 Hours (TOPAR4), Comparing a Single Dose of Sildenafil 100 mg to a Single Dose of Placebo.

    The Total Pain Relief (TOPAR) Scale rates the level of pain relief on a scale of 0=None, 1=Mild, 2=Moderate, 3=Excellent, 4=Complete. The TOPAR scale was completed each hour after administration of study drug for a total of 4 hours. The 4 hourly scores were summed for a final TOPAR4 score that ranged between 0 and 16, with higher values indicating greater pain relief over time. Missing TOPAR scores after the first hour were imputed using the last-observation-carried-forward approach.

    Hours 1, 2, 3 and 4.

Secondary Outcomes (1)

  • Improvement in Pain Severity Determined by Visual Analog Scale (VAS).

    Each hour of the study (0, 1, 2, 3, 4).

Study Arms (2)

Sildenafil Citrate

EXPERIMENTAL

A single vaginal dose of Viagra 100 mg.

Drug: Sildenafil Citrate

Placebo

PLACEBO COMPARATOR

A single vaginal dose of placebo.

Drug: Placebo

Interventions

Sildenafil CitrateDRUG

A single vaginal dose of sildenafil citrate 100 mg and monitored for 4 hours.

Also known as: Viagra
Sildenafil Citrate
PlaceboDRUG

A single vaginal dose of placebo and monitored for 4 hours.

Also known as: Sugar Pill
Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primary dysmenorrhea at current visit, with a visual analogue scale (VAS) score of \>35; pain defined as moderate or severe on a categorical of none, mild, moderate, severe.

You may not qualify if:

  • Secondary dysmenorrhea
  • Any current medication
  • Serious medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Gradiska General Hospital

Strossmayerova 17, Zagreb, Croatia

Location

Related Publications (1)

  • Dmitrovic R, Kunselman AR, Legro RS. Sildenafil citrate in the treatment of pain in primary dysmenorrhea: a randomized controlled trial. Hum Reprod. 2013 Nov;28(11):2958-65. doi: 10.1093/humrep/det324. Epub 2013 Aug 6.

    PMID: 23925396DERIVED

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Sildenafil CitrateSugars

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCarbohydrates

Results Point of Contact

Title
Richard S Legro MD
Organization
MS Hershey Medical Center
rsl1@psu.edu
717-531-8478

Study Officials

  • Richard Legro, M.D.

    Penn State University College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Obstetrics and Gynecology and Public Health Sciences

Study Record Dates

First Submitted

July 20, 2005

First Posted

July 22, 2005

Study Start

May 1, 2007

Primary Completion

June 1, 2011

Study Completion

August 1, 2011

Last Updated

December 23, 2015

Results First Posted

December 23, 2015

Record last verified: 2015-11

Locations

CR(1)