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NCT00128934 Clinical Trial

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

Premenstrual Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00128934
Other study ID # 0858A4-316
Secondary ID
Status Completed
Phase Phase 3
First received August 8, 2005
Last updated December 18, 2007
Start date August 2005
Est. completion date December 2007

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Canada: Health CanadaUnited States: Food and Drug Administration
Study type Interventional

Clinical 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).

Other known NCT identifiers
  • NCT00278720

Recruitment information / eligibility
Status Completed
Enrollment 744
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• levonorgestrel/ethinyl estradiol

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
Secondary Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
See also
  Status Clinical Trial Phase
Completed NCT02481973 - The Effect of Individualised Homoeopathic Treatment Using the Grant Bentley Method in Premenstrual Syndrome Phase 2
Completed NCT00195559 - Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder Phase 3
Completed NCT00048854 - Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder Phase 1/Phase 2
Completed NCT00965562 - Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS) N/A
Completed NCT05349344 - Effect of Aerobic Exercise on Premenstrual Syndrome Symptoms (PMS). N/A
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Completed NCT03298607 - The Impact of Serelys PMS on Symptoms of PMS Phase 3
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