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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
Posted Date: Oct 16, 2015
- Investigator: Michael Thomas
- Type of Study: Drug
The purpose of this study is to find out: • If there are any effects of the study pill on menstrual periods, ovulation (releasing an egg from the ovary), preventing pregnancies and bleeding; • How safe the study pill is to use every day; • How much SPRM (selective progesterone receptor modulator), estrogen-free hormone needs to be in the study pill to make sure that it prevents pregnancy; • How the hormone in the study pill affects your rate of ovulation (how often you release an egg); • How the hormone in the study pill is absorbed by the body; • Whether the study drug in the study pill affects your everyday life and if it causes any side effects different from what we know about side effects from other contraceptives; if the side-effects from this study pill are more or less serious than the side-effects from other hormonal contraceptives. The study pill used in this study is investigational and is being developed as a possible new method of birth control. The study pill is made of ulipristal acetate, an estrogen-free hormonal contraceptive that contains a selective progesterone-receptor modulator (SPRM). A SPRM is a hormone that may block the action of the hormone progesterone. The oral pill releases the hormone into your body. The hormone is intended to keep women from releasing an egg so they do not get pregnant. Other birth control pills work the same way.
You Are Being Asked To Take Part In This Research Study Because You Are 18-35 Years Old And Have A Regular Menstrual Period Every 21-35 Days. To Take Part In This Study, You Must Not Be At Risk For Becoming Pregnant. You Do Not Have To Be Sexually Active To Take Part In This Study. If You Are Sexually Active In A Heterosexual Relationship, Either Your Partner Must Be Surgically Sterile With A Vasectomy, You Must Have Previously Had Your Tubes Tied (Tubal Ligation) Or You Must Use Another Non-Hormonal Barrier Method Of Birth Control Such As A Condom Or Diaphragm To Prevent Pregnancy. You Must Not Rely Upon The Study Pill To Prevent You From Becoming Pregnant.
Contraception, Healthy Subjects, Healthy Women, Women's Health, Obstetrics & Gynecology
For More Information:
Debbie Boerschig Or Tiffany Rupert