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AzTrials

Menstruation DisturbancesPhase 3NCT00128934

Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder

A Phase 3 study testing levonorgestrel/ethinyl estradiol in people with Menstruation Disturbances and Premenstrual Syndrome, run by Wyeth is now a wholly owned subsidiary of Pfizer at 83 sites in 2 countries.

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

The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS). Read more about this study

Who is it for?
Ages 18 to 49 years, women only
What is being tested?
levonorgestrel/ethinyl estradiol
How many people
744 participants
Where
83 sitesin 2 countries
Study dates
Aug 2005to Dec 2007
Phase
Phase 3
Are there results?
None posted in the registry

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 49 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Generally healthy, women aged 18 to 49 years.
  • History of severe PMS symptoms over the last year, as determined by the investigator.
  • Regular 21 to 35 day menstrual cycle for 2 months prior to first study visit.

Who cannot join

  • Major depressive disorder requiring antidepressant treatment or hospitalization within the last 3 years.
  • Contraindication to combination oral contraceptives.
  • Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.
  • Other exclusions apply.

Trial locations and contacts

83 sites in 2 countries.

83 sites in 2 countries

United States69 sites

  • Study site

    Adventure, Florida, 33180

  • Study site

    Atlanta, Georgia, 30328

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Austin, Texas, 78756

  • Study site

    Boise, Idaho, 83712

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Brooklyn, New York, 11235

  • Study site

    Buffalo, New York, 14214

  • Study site

    Burlington, Vermont, 05401

  • Study site

    Carmichael, California, 95608

  • Study site

    Carrollton, Texas, 75010

  • Study site

    Charlottesville, Virginia, 22903

  • Study site

    Chicago, Illinois, 60631

  • Study site

    Chicago, Illinois, 60634

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Clearwater, Florida, 33761

  • Study site

    Cleveland, Ohio, 44122

  • Study site

    Conroe, Texas, 77304

  • Study site

    Denver, Colorado, 80202

  • Study site

    East Providence, Rhode Island, 02914

  • Study site

    Eugene, Oregon, 97401

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Fayetteville, North Carolina, 28304

  • Study site

    Fort Myers, Florida, 33916

  • Study site

    Glen Burnie, Maryland, 21061

  • Study site

    Greer, South Carolina, 29654

  • Study site

    Hialeah, Florida, 33016

  • Study site

    Hilton Head Island, South Carolina, 29926

  • Study site

    Jonesboro, Arkansas, 72401

  • Study site

    Lakewood, Colorado, 80228

  • Study site

    Lakewood, Washington, 98499

  • Study site

    Lexington, Kentucky, 40509

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Longmont, Colorado, 80501

  • Study site

    Los Angeles, California, 90095

  • Study site

    Medford, Oregon, 97504

  • Study site

    Middletown, Connecticut, 06457

  • Study site

    Mogadore, Ohio, 44260

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New Bern, North Carolina, 28562

  • Study site

    New Haven, Connecticut, 06510

  • Study site

    New Orleans, Louisiana, 70114

  • Study site

    New York, New York, 10021

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Pembroke Pines, Florida, 33024

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Philadelphia, Pennsylvania, 19114

  • Study site

    Pittsfield, Massachusetts, 01201

  • Study site

    Renton, Washington, 98055

  • Study site

    Richmond, Virginia, 23230

  • Study site

    Richmond, Virginia, 23233

  • Study site

    Richmond, Virginia, 23294

  • Study site

    Rochester, New York, 14609

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92103

  • Study site

    Sandy City, Utah, 84070

  • Study site

    Savannah, Georgia, 31406

  • Study site

    Scottsdale, Arizona, 85251

  • Study site

    South Bend, Indiana, 46601

  • Study site

    Springfield, Massachusetts, 01107

  • Study site

    Tucson, Arizona, 85715

  • Study site

    Tulsa, Oklahoma, 74135

  • Study site

    Washington D.C., District of Columbia, 20037

  • Study site

    Waterbury, Connecticut, 06708

  • Study site

    West Palm Beach, Florida, 33407

  • Study site

    Wexford, Pennsylvania, 15090

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada14 sites

  • Study site

    Edmonton, Alberta, T6G 2C8

  • Study site

    Edmonton, Alberta, T6L 5X8

  • Study site

    Hamilton, Ontario, L8N 4A6

  • Study site

    Hull, Quebec, J9A 1K7

  • Study site

    Kelowna, British Columbia, V1Y 2H4

  • Study site

    Montréal, Quebec, H1T 1P6

  • Study site

    Montréal, Quebec, H3A 1A1

  • Study site

    Pointe-Claire, Quebec, H9R 4S3

  • Study site

    Québec, Quebec, G1R 2W8

  • Study site

    Québec, Quebec, G1S 2L6

  • Study site

    Shawinigan, Quebec, G9N 2H6

  • Study site

    Sherbrooke, Quebec, J1H 4J6

  • Study site

    Toronto, Ontario, M9W 4L6

  • Study site

    Vancouver, British Columbia, V6H 3N1

Other trials in Canada

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder

The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS).

Being tested
levonorgestrel/ethinyl estradiol
Keywords
Premenstrual Syndrome (PMS), Hormone Therapy
Medical subject headings
Menstruation Disturbances, Premenstrual Syndrome

What participants receive

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

  • levonorgestrel/ethinyl estradiolDrug

What is being measured

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

  1. Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score

Secondary outcomes (1)

  1. Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle

Timeline

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

  1. First posted10 Aug 2005 (estimated)
  2. Study startAug 2005
  3. Study completionDec 2007

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
744 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00128934
Sponsor's protocol ID
0858A4-316
Status last verified
Dec 2007
First submitted
8 Aug 2005
Last updated
27 Dec 2007
Results posted
No

Publications

  • Halbreich U, Freeman EW, Rapkin AJ, Cohen LS, Grubb GS, Bergeron R, Smith L, Mirkin S, Constantine GD. Continuous oral levonorgestrel/ethinyl estradiol for treating premenstrual dysphoric disorder. Contraception. 2012 Jan;85(1):19-27. doi: 10.1016/j.contraception.2011.05.008. Epub 2011 Jul 13.

    PubMed 22067793

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing levonorgestrel/ethinyl estradiol in people with Menstruation Disturbances and Premenstrual Syndrome, run by Wyeth is now a wholly owned subsidiary of Pfizer at 83 sites in 2 countries.

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 4 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 27 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Canada. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Daily Record of Severity of Problems (DRSP) 21-item total daily score. 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 NCT00128934, 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 27 Dec 2007.

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