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

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

Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00161681

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

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer Identifier: NCT00161681     History of Changes
Other Study ID Numbers: 0858A2-322
B3121024 ( Other Identifier: Pfizer )
Study First Received: September 7, 2005
Last Updated: February 7, 2013

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

Additional relevant MeSH terms:
Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Polyestradiol phosphate
Ethinyl Estradiol
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 23, 2017