Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00161681
First received: September 7, 2005
Last updated: February 7, 2013
Last verified: May 2007
  Purpose

The purpose of this study is to determine whether LNG/EE is effective in the treatment of menstrual cycle related symptoms.


Condition Intervention Phase
Premenstrual Syndrome
Drug: Levonorgestrel/Ethinyl Estradiol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Levonorgestrel 90 Mcg and Ethinyl Estradiol 20 Mcg in a Continuous Daily Regimen on Menstrual Cycle-Related Symptoms

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • To evaluate the efficacy of a continuous-use OC regimen containing a combination of LNG/EE in preventing moderate to severe cycle-related symptoms compared with placebo

Secondary Outcome Measures:
  • To evaluate the effects of this LNG/EE regimen on work productivity and subject satisfaction in subjects with moderate to severe cycle-related symptoms at baseline compared with placebo

Estimated Enrollment: 200
Study Start Date: July 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy women aged 18 to 49 years
  • Regular 21 to 35 day menstrual cycles for 3 months prior to study visit 1
  • History of menstrual cycle related symptoms as determined by the investigator.

Exclusion Criteria:

  • Contraindication to combination oral contraceptives
  • Depression requiring hospitalization or associated with suicidal ideation within the last 3 years
  • Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161681

  Show 48 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00161681     History of Changes
Other Study ID Numbers: 0858A2-322, B3121024
Study First Received: September 7, 2005
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Levonorgestrel
ethinyl estradiol
premenstrual syndrome
menstrual cycle related symptoms

Additional relevant MeSH terms:
Premenstrual Syndrome
Syndrome
Disease
Menstruation Disturbances
Pathologic Processes
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Levonorgestrel
Polyestradiol phosphate
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014