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

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ClinicalTrials.gov Identifier: NCT00319163
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : August 7, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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 Type : Interventional  (Clinical Trial)
Enrollment : 26 participants
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 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006





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)


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319163


Locations
United States, Florida
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

ClinicalTrials.gov Identifier: NCT00319163     History of Changes
Other Study ID Numbers: 0858A2-108
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: August 7, 2009
Last Verified: August 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
oral contraceptive
therapeutic equivalency
contraceptives, oral, combined

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Levonorgestrel
Contraceptives, Oral, Combined
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral