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Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception

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Wyeth

Status and phase

Completed
Phase 3

Conditions

Oral Contraceptive

Treatments

Drug: Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00248963
0858A2-315

Details and patient eligibility

About

To evaluate the contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen and to evaluate the safety compared to LNG 100 mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen.

Sex

Female

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy women aged 18 to 49 years who are willing to rely upon a combination birth control pill as their only method of contraception.
  • Women must be sexually active and at risk for becoming pregnant.
  • Women must have had regular (21- to 35- day) menstrual cycles for the 3-month period preceding study visit 1.

Exclusion criteria

  • High blood pressure
  • Age greater then 34 and smoking more than 15 cigarettes per day.
  • Depression requiring hospitalization or associated with suicidal ideation within the last 3 years.

Trial design

Primary purpose

Educational/Counseling/Training

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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