Study Comparing Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women

An Open-label, Single-dose, Randomized, 2-period, Crossover, Bioequivalence Study to Compare Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00319163

Enrollment

Registered

2006-04-27

Start date

2006-05-31

Completion date

2006-11-30

Last updated

2009-08-07

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

Conditions

Healthy

Keywords

oral contraceptive, therapeutic equivalency, contraceptives, oral, combined

Brief summary

Primary Objective: To determine the bioequivalence between the clinical batch process and the new processes for manufacturing LNG/EE. Secondary Objective: To obtain additional safety and tolerability data concerning LNG/EE in healthy, cycling women.

Interventions

DRUGlevonorgestrel/ethinyl estradiol

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Women 18 - 35 years of age * Non-smokers

Exclusion criteria

* History of thromboembolic disease * Prior adverse experiences with oral contraceptives

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic sampling over the course of 4 days following two different formulations of the same compound	—

Secondary

Measure	Time frame
Additional safety--clinical labs	—
electrocardiograms (ECGs)	—
vital signs	—
and adverse event recording over 4 days following administration of each formulation (LNG/EE)	—

Countries

United States

Outcome results

None listed

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