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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00161681

Enrollment

200

Registered

2005-09-12

Start date

2005-07-31

Completion date

2006-08-31

Last updated

2013-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premenstrual Syndrome

Keywords

Levonorgestrel, ethinyl estradiol, premenstrual syndrome, menstrual cycle related symptoms

Brief summary

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

Interventions

DRUGLevonorgestrel/Ethinyl Estradiol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 49 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026