DysmenorrheaPhase 2NCT00196313

A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain

A Phase 2 study testing levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets in people with Dysmenorrhea, run by Duramed Research at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 13 weeks of treatment with the option to extend blinded therapy for an additional 13 weeks. Read more about this study

Who is it for?: Ages Up to 17 years, women only
Conditions the study is for: Dysmenorrhea
What is being tested?: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 95 participants
Where: 13 sitesUnited States
Study dates: May 2005to Oct 2008
Phase: Phase 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 Up to 17 years
Women only
No healthy volunteers
Child

Who may be able to join

Sexually naïve and agree to abstain from sex during the study
Moderate to severe menstrual-related pelvic pain
Regular spontaneous menstrual cycles

Who cannot join

Any contraindication to the use of oral contraceptives
Treatment with an oral contraceptive within the previous 3 months
Previous treatment failure with an extended oral contraceptive regimen

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Duramed Investigational Site
Cincinnati, Ohio, 45229
Duramed Investigational Site
Cleveland, Ohio, 44109
Duramed Investigational Site
Columbus, Ohio, 43205
Duramed Investigational Site
Decatur, Georgia, 30034
Duramed Investigational Site
Denver, Colorado, 80218-1088
Duramed Investigational Site
Louisville, Kentucky, 40202
Duramed Investigational Site
Medford, Oregon, 97504
Duramed Investigational Site
Philadelphia, Pennsylvania, 19114
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15213
Duramed Investigational Site
Providence, Rhode Island, 02903
Duramed Investigational Site
Salt Lake City, Utah, 84124
Duramed Investigational Site
St Louis, Missouri, 63110
Duramed Investigational Site
Willow Grove, Pennsylvania, 19090

Other trials in United States

About this study

Official title: A Multicenter Study to Compare the Efficacy of an Extended-cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-free Interval to Placebo for the Treatment of Cyclic Pelvic Pain in Adolescents

Conditions: Dysmenorrhea
Being tested: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets, Placebo tablet
Keywords: cyclic pelvic pain, dysmenorrhea, oral contraceptives
Medical subject headings: Dysmenorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tabletsDrug
Also called Seasonique
1 tablet daily by mouth
Placebo tabletDrug
1 tablet daily by mouth

Study groups in NCT00196313
Study group	Role	What they receive
1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet	Experimental	Not described Receives: Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
2	Placebo comparator	Not described Receives: Drug: Placebo tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change in Average Severity for Abdominal/Pelvic Pain
Defined as the sum of pain scores divided by the total number of days in which the subject experienced abdominal/pelvic pain, from baseline to Week 13 The severity of the pain was assessed using a 4-points scale (0 = "None", 1 = "Mild", 2 = "Moderate", 3 = "Severe")
Measured: Baseline to end of 13-week treatment period

Secondary outcomes (4)

Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain
Maximum pain severity score was calculated by identifying each subject's maximum recorded pain severity from baseline to end of Week 13.
The severity of the pain was assessed using a 4-points scale (0 = "None", 1 = "Mild", 2 = "Moderate", 3 = "Severe")
Measured: Baseline to end of Week 13
Incidence of Menstrual Bleeding and /or Spotting
Measured: Baseline to end of Week 13
Number of Days Missed From School/Work or Other Activities
Measured: 13-week treatment period
Analgesic Use
number of days analgesic (pain) medication was used over the 13 week treatment period
Measured: 13-week treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2005Oct 2008

First posted20 Sep 2005 (estimated)
Study startMay 2005
Primary completionOct 2008
Study completionOct 2008

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.
Other trials for DysmenorrheaStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00196313
Sponsor's protocol ID: DR-PSE-306
Status last verified: Aug 2016
First submitted: 12 Sep 2005
Last updated: 22 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dysmenorrhea trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Study to Compare the Efficacy of an Extended-cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-free Interval to Placebo for the Treatment of Cyclic Pelvic Pain in Adolescents
ClinicalTrials.gov ID: NCT00196313
Acronym / sponsor ID: DR-PSE-306
Conditions: Dysmenorrhea
Keywords: cyclic pelvic pain, dysmenorrhea, oral contraceptives
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: Duramed ResearchIndustry (pharma, biotech, devices)
Study start: May 2005
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 20 Sep 2005 (estimated)
Results: Posted 25 May 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet	Experimental	Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
2	Placebo comparator	Drug: Placebo tablet

Who may qualify

Ages: Up to 17 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Sexually naïve and agree to abstain from sex during the study
Moderate to severe menstrual-related pelvic pain
Regular spontaneous menstrual cycles

Key exclusion criteria (3 listed)

Any contraindication to the use of oral contraceptives
Treatment with an oral contraceptive within the previous 3 months
Previous treatment failure with an extended oral contraceptive regimen

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
levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tabletsAlso: Seasonique1 tablet daily by mouth	Drug	1 levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablet
Placebo tablet1 tablet daily by mouth	Drug	2

Primary outcome

Mean Change in Average Severity for Abdominal/Pelvic Pain
Time frame: Baseline to end of 13-week treatment period
Defined as the sum of pain scores divided by the total number of days in which the subject experienced abdominal/pelvic pain, from baseline to Week 13 The severity of the pain was assessed using a 4-points scale (0 = "None", 1 = "Mild", 2 = "Moderate", 3 = "Severe")

4 secondary outcomes

Change From Baseline in Maximum Severity of Abdominal/Pelvic Pain
Time frame: Baseline to end of Week 13
Incidence of Menstrual Bleeding and /or Spotting
Time frame: Baseline to end of Week 13
Number of Days Missed From School/Work or Other Activities
Time frame: 13-week treatment period
Analgesic Use
Time frame: 13-week treatment period

Results and safety

Results posted to the registry on 25 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Seasonique	47	36
Placebo	48	40

Primary outcome: Mean Change in Average Severity for Abdominal/Pelvic Pain

Time frame: Baseline to end of 13-week treatment period. Least squares mean (Standard Error). Unit: units on a scale

Measure	Seasonique n = 36	Placebo n = 40
Value	-0.45 (0.060)	-0.19 (0.058)

Population analysed: Complete Cohort: consisted of all randomized subjects who completed the full term of study participation (13 weeks) and who had no recorded protocol violations that would have excluded the from analysis.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Seasonique	2 of 47 (4.3%)	47 of 47 (100%)	Not reported
Placebo	0 of 48 (0%)	17 of 48 (35.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets in people with Dysmenorrhea, run by Duramed Research at 13 sites in United States.

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 3 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 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. 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 phase mean?

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 25 May 2012). 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?

Mean Change in Average Severity for Abdominal/Pelvic Pain (time frame: Baseline to end of 13-week treatment period). 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 NCT00196313.

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 22 Sep 2016.