OHSU

IRB #

IRB00010023

Title

A phase IIb randomized, double blind, comparative study to assess the efficacy, safety, tolerability and inhibition of ovulation of two continuous regimens of oral daily 5 mg or 10 mg of ulipristal acetate (UPA), versus a dose of 5.0mg UPA for 24/4 days

Principal Investigator

Jeffrey Jensen

Study Purpose

The primary objective is to compare the pharmacodynamic effects of 2 continuous
dose regimens of ulipristal acetate 5.0 and 10.0 mg-only oral contraception, versus a
24/4 day regimen of UPA 5.0 mg. Secondarily the tolerability and effects of the three
different doses will be compared for bleeding, follicle growth, endometrial safety and
subject satisfaction.

Medical Condition(s)

Female use, oral contraceptive pill in healthy subjects

Eligibility Criteria

Healthy females, 18-35, regular menstrual cycles, not pregnant, not currently using hormonal contraceptives, willing to abstain from sex, use barrier methods, have had a tubal ligation, or have a partner with a vasectomy.

Age Range

18 - 35

Healthy Volunteers Needed

Yes

Duration of Participation

Approximately 7 months

Minors Included

No

Contact

Women's Health Research Unit Confidential Recruitment Line: 503-494-3666

Sponsor

HRA Pharma and Eunice Kennedy Shriver National Institute of Child Health and
Human Development (NICHD)

Recruitment End

Compensation Provided

Yes

Compensation

Main study: $40 (screen only)
$2,180(screening through completion)
Optional PK: $500
Max total: $2,680
(Based on average of 47 visits)


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