Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2004-10-31

Brief Summary

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To determine the ability of a monophasic oral contraceptives ("OC") regimen of Levonorgestrel ("LNG") 90 mg and Ethinyl Estradiol ("EE") 20 mg to inhibit ovulation during 84 days of continuous therapy.

Detailed Description

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Conditions

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Ovulation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Levonorgestrel

Intervention Type DRUG

Ethinyl Estradiol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy women of legal age of consent who are willing to use a combination OC.
* Subjects must be under the age of 36 at the time of enrollment (visit 3).
* Subjects must have had regular (24 to 32 day) menstrual cycles for the 3-month period preceding entry into the pretreatment observation cycle, excluding postabortal and nonnursing postpartum subjects. Postabortal and nonnursing postpartum subjects must have completed at least 1 regular (24 to 32 day) spontaneous menstrual cycle before entry into the pretreatment observation cycle. The pretreatment observation cycle for all subjects will begin on day 1 of the subsequent spontaneous menses.

Other inclusions apply.

Exclusion Criteria

A history or the presence of any of the following will prevent enrollment:

* Thrombophlebitis, thrombosis, or thromboembolic disorders.
* Deep vein thrombosis.
* Pulmonary embolism.

Other exclusions apply.

Minimum Eligible Age

0 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

References

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Archer DF, Kovalevsky G, Ballagh SA, Grubb GS. Ovarian activity and safety of a novel levonorgestrel/ethinyl estradiol continuous oral contraceptive regimen. Contraception. 2009 Sep;80(3):245-53. doi: 10.1016/j.contraception.2009.03.006. Epub 2009 May 2.

Reference Type DERIVED

PMID: 19698816 (View on PubMed)

Other Identifiers

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0858A2-208

Identifier Type: -

Identifier Source: org_study_id