Study Evaluating the Bioequivalence of Levonorgestrel/Ethinyl Estradiol Combinations in Cycling Women

Contraception Clinical Trial

Official title:

An Open-Label, Single-Dose, Randomized, 2-Period, Crossover, Bioequivalence Study to Compare Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg in 2 Dosage Forms With Different Dissolution Characteristics in Healthy, Cycling Women

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00447863
• Other study ID #: 0858A2-109
• Status: Withdrawn
• Phase: Phase 1
• Start date: August 2007
• Est. completion date: August 2007

Study information

• Verified date: August 2021
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Levonorgestrel/ethinyl estradiol (LNG/EE) is an investigational drug that is being developed as an oral contraceptive (birth control pill). The purpose of this trial is to compare different preparations of LNG/EE by assessing the way they are absorbed into the blood.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Women aged 18 to 35 years.
• Healthy as determined by the investigator on the basis of medical history and screening evaluations.
• Must have a history of normal menstrual cycles (24 to 34 days) for the 3-month period preceding entry into the study.

Exclusion Criteria:

• Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
• Presence, history, or family history of thrombophlebitis, thrombosis, or thromboembolitic disorders, deep vein thrombosis, pulmonary embolism, or known coagulopathy.
• Bethesda system report of low-grade squamous intraepithelial lesion or greater for a cervical cytologic smear obtained within the last 3 months.

Related Conditions & MeSH terms

• Contraception

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the bioequivalence of 2 batches of LNG/EE tablets with different dissolution characteristics
Secondary	To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women