NCT00319163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started May 2006

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

August 7, 2009

Status Verified

August 1, 2009

Enrollment Period

6 months

First QC Date

April 26, 2006

Last Update Submit

August 5, 2009

Conditions

Healthy

Keywords

oral contraceptivetherapeutic equivalencycontraceptives, oral, combined

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

  • Additional safety--clinical labs

  • electrocardiograms (ECGs)

  • vital signs

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

Interventions

levonorgestrel/ethinyl estradiolDRUG

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Miami, Florida, 33126, United States

Location

MeSH Terms

Interventions

Ethinyl Estradiol-Norgestrel Combination

Intervention Hierarchy (Ancestors)

Ethinyl EstradiolNorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsNorgestrelNorpregnenesEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 26, 2006

First Posted

April 27, 2006

Study Start

May 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

August 7, 2009

Record last verified: 2009-08

Locations

US(1)