A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis
Status: | Terminated |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 18 - 49 |
Updated: | 12/1/2017 |
Start Date: | April 2010 |
A Double Blind, Randomized, Controlled, Multicenter, Efficacy and Safety Study of Oral BGS649 vs. Placebo (Each Co-administered With a Combined Oral Contraceptive) Assessing Pain Response in Patients With Refractory Endometriosis
The purpose of this study is to determine efficacy, safety, tolerability and pharmacokinetics
of multiple doses of BGS649 with concurrent daily administration of combined oral
contraception in patients with refractory endometriosis
of multiple doses of BGS649 with concurrent daily administration of combined oral
contraception in patients with refractory endometriosis
Inclusion Criteria:
- Must have surgical diagnosis of endometriosis est. w/in 5 years before screening.
Subjects must have self reported moderate to severe pelvic pain at screening to be
confirmed during the run-in-phase
- Subjects with moderate to severe pelvic pain who were refractory to surgery
(persistent or recurrent pelvic pain within 24 months after any therapeutic surgery)
and at least two hormonal therapies from two different classes, including one approved
hormonal therapy
Exclusion Criteria:
- Subjects who have undergone hysterectomy or bilateral oophorectomy.
- Surgical treatment of endometriosis within 3 months before screening.
- Subjects who are pregnant or who were pregnant within 3 months of visit one.
- Subjects who are nursing or lactating
- Subjects who are tobacco smokers.
Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
43
sites
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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