CClinicalTrials.gg
CompletedNCT00319163Updated Aug 7, 2009

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

A Phase 1 interventional study of levonorgestrel/ethinyl estradiol in Healthy, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 1 site in United States. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-08-07.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Non-randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • oral contraceptive
  • therapeutic equivalency
  • contraceptives, oral, combined
03

In context

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • History of thromboembolic disease
  • Prior adverse experiences with oral contraceptives
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
26 participants

Interventions

  • Druglevonorgestrel/ethinyl estradiol
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  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)

07

Study locations

1 site
  • Miami, Florida 33126, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00319163
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Apr 27, 2006
Start date
May 2006
Primary completion
Nov 2006
Completion
Nov 2006
Last update
Aug 7, 2009

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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