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

This study has been terminated.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01116440
First received: May 3, 2010
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Pelvic Pain Associated With Refractory Endometriosis
Drug: BGS649
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change from baseline in mean pelvic pain score [ Time Frame: During 1st & 2nd 4 week periods of trt ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: April 2010
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116440

  Show 44 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01116440     History of Changes
Other Study ID Numbers: CBGS649A2202
Study First Received: May 3, 2010
Last Updated: July 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Menstrual pain
Refractory endometriosis
Pelvic pain

Additional relevant MeSH terms:
Endometriosis
Pelvic Pain
Genital Diseases, Female
Pain
Signs and Symptoms
Contraceptives, Oral
Contraceptives, Oral, Combined
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014