DysmenorrheaPhase 1/2NCT00123162
Viagra in the Treatment of Primary Dysmenorrhea
A Phase 1/2 study testing Sildenafil Citrate in people with Dysmenorrhea, run by Milton S. Hershey Medical Center at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Sildenafil Citrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCroatia
- Study dates
- May 2007to Aug 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Secondary dysmenorrhea
- Any current medication
- Serious medical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sildenafil Citrate in the Treatment of Primary Dysmenorrhea
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.
Read the detailed description
It is well established that excess prostaglandin production in primary dysmenorrhea leads to ischemia of the uterine muscle, which consequently causes pelvic pain. A large number of drugs have been studied for pain relief in dysmenorrhea patients, with non-steroid anti-inflammatory drugs (NSAIDS) being the most effective with the overall success rate of more than 75%. Sildenafil citrate (Viagra) is an inhibitor that augments the vasodilatory effects of nitric oxide by preventing the degradation of Cyclic guanosine monophosphate (cGMP) in the uterine muscle. Sildenafil is commonly used in the treatment of male erectile dysfunction, pulmonary hypertension in children and adults, and in vitro fertilization. To date it has not been used in the treatment of primary dysmenorrhea.
- Conditions
- Dysmenorrhea
- Being tested
- Sildenafil Citrate, Placebo
- Keywords
- Sildenafil
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil CitrateDrug
Also called Viagra
A single vaginal dose of sildenafil citrate 100 mg and monitored for 4 hours.
PlaceboDrug
Also called Sugar Pill
A single vaginal dose of placebo and monitored for 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil Citrate | Experimental | A single vaginal dose of Viagra 100 mg. Receives: Drug: Sildenafil Citrate |
| Placebo | Placebo comparator | A single vaginal dose of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Hours 1, 2, 3 and 4.
Secondary outcomes (1)
Improvement in Pain Severity Determined by Visual Analog Scale (VAS).
The Visual Analog Scale (VAS) assesses pain intensity. The scale is 100 mm long; the extremes of the scale are to the left, "no pain" and to the right, "worst pain I have ever felt." The VAS score is determined by measuring the distance (in mm) from the left side of the scale to the point that the patient marked. The score ranges from 0 to 100, with higher values indicating greater pain.
Measured: Each hour of the study (0, 1, 2, 3, 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startMay 2007
- Primary completionJun 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Richard S. Legro, M.D., Milton S. Hershey Medical Center
- Investigators
- Richard Legro, M.D., Principal investigator, Penn State University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123162
- Sponsor's protocol ID
- 20477
- Status last verified
- Nov 2015
- First submitted
- 20 Jul 2005
- Last updated
- 23 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23925396
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sildenafil Citrate in the Treatment of Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT00123162
- Acronym / sponsor ID
- 20477
- Conditions
- Dysmenorrhea
- Keywords
- Sildenafil
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- May 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Jul 2005 (estimated)
- Results
- Posted 23 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is well established that excess prostaglandin production in primary dysmenorrhea leads to ischemia of the uterine muscle, which consequently causes pelvic pain. A large number of drugs have been studied for pain relief in dysmenorrhea patients, with non-steroid anti-inflammatory drugs (NSAIDS) being the most effective with the overall success rate of more than 75%. Sildenafil citrate (Viagra) is an inhibitor that augments the vasodilatory effects of nitric oxide by preventing the degradation of Cyclic guanosine monophosphate (cGMP) in the uterine muscle. Sildenafil is commonly used in the treatment of male erectile dysfunction, pulmonary hypertension in children and adults, and in vitro fertilization. To date it has not been used in the treatment of primary dysmenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil Citrate | Experimental | Drug: Sildenafil CitrateA single vaginal dose of Viagra 100 mg. |
| Placebo | Placebo comparator | Drug: PlaceboA single vaginal dose of placebo. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Secondary dysmenorrhea
- Any current medication
- Serious medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil CitrateAlso: ViagraA single vaginal dose of sildenafil citrate 100 mg and monitored for 4 hours. | Drug | Sildenafil Citrate |
| PlaceboAlso: Sugar PillA single vaginal dose of placebo and monitored for 4 hours. | Drug | Placebo |
Primary outcome
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.
Time frame: Hours 1, 2, 3 and 4.
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.
1 secondary outcome
Improvement in Pain Severity Determined by Visual Analog Scale (VAS).
Time frame: Each hour of the study (0, 1, 2, 3, 4).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23925396Dmitrovic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Legro, M.D. principal investigator
Penn State University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sildenafil Citrate in people with Dysmenorrhea, run by Milton S. Hershey Medical Center at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Hours 1, 2, 3 and 4.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00123162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2015.