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

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00319163
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Duration (Months): 6
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: levonorgestrel/ethinyl estradiol	Phase 1

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: 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
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Nov 1, 2006
• Actual Study Completion Date: Nov 1, 2006

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetic sampling over the course of 4 days following two different formulations of the same compound []

Secondary Outcome Measures

1. Additional safety--clinical labs []

2. electrocardiograms (ECGs) []

3. vital signs []

4. and adverse event recording over 4 days following administration of each formulation (LNG/EE) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Miami	Florida	United States	33126

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00319163
• Other Study ID Numbers: 0858A2-108
• First Posted: Apr 27, 2006
• Last Update Posted: Aug 7, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: oral contraceptive; therapeutic equivalency; contraceptives, oral, combined
• Additional relevant MeSH terms: Levonorgestrel; Ethinyl Estradiol; Estradiol

Study Results

No Results Posted as of Aug 7, 2009