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A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01116440
Recruitment Status : Terminated
First Posted : May 5, 2010
Last Update Posted : July 21, 2011
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Pelvic Pain Associated With Refractory Endometriosis Drug: BGS649 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2010
Actual Primary Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BGS649 co-administered with Levora 28™ Drug: BGS649
0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg will be administered at randomization, week 4, and week 8 at the study site.

Placebo Comparator: Placebo co-administered with Levora 28™ Drug: Placebo
Placebo matching BGS649 will be provided by Novartis as capsules for oral administration. Three capsules of placebo will be administered at randomization, week 4, and week 8 at the study site.

Primary Outcome Measures :
  1. To demonstrate that from baseline of mean pelvic pain score during month 3 is significantly greater on BGS649 treatment(plus COC)combined oral contraceptive as compared to placebo(plus COC)in patients with refractory endometriosis. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. The change from baseline in mean pelvic pain score [ Time Frame: During 1st & 2nd 4 week periods of trt ]
  2. The proportion of patients achieving a response in the pelvic pain score (greater than or equal to 1-point improvement from baseline on the modified B&B scale) [ Time Frame: During the 1st, 2nd & 3rd 4 week periods of trt ]
  3. The change from baseline in the pain associated with sexual intercourse (NRS) and the number of days the patient had sexual intercourse [ Time Frame: During the first, second, and third 4-week periods of treatment. ]
  4. The percent change from baseline in mean pelvic pain (NRS) score defined as >=2-point improvement in the NRS & >=30% improvement in the NRS [ Time Frame: month 1, 2 & 3 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01116440

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Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
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Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT01116440     History of Changes
Other Study ID Numbers: CBGS649A2202
First Posted: May 5, 2010    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: July 2011

Keywords provided by Novartis:
Menstrual pain
Refractory endometriosis
Pelvic pain

Additional relevant MeSH terms:
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Pelvic Pain
Genital Diseases, Female
Neurologic Manifestations
Signs and Symptoms