BGS649 Monotherapy in Moderate to Severe Endometriosis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01190475
First received: August 19, 2010
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.


Condition Intervention Phase
Endometriosis
Drug: BGS649
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Double-dummy, Placebo-controlled Study of Oral BGS649 Monotherapy Assessing Safety and Tolerability in Patients With Moderate to Severe Endometriosis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: To evaluate the safety & tolerability of multiple dosing of BGS649 at two dose levels over 53 months in pre-menopausal women with moderate-severe endometriosis, as assessed by serial transvaginal ultrasonography & bone resorption biomarker [ Time Frame: 8 months. Evaluate safety and tolerability from baseline up to 3 months of treatment via transvaginal ultrasonography and up to 5 months from baseline to month 5 via bone resorption biomarker. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measure: To evaluate the pharmacokinetic profile of BGS649 following multiple dosing at two dose levels over 3 months in pre-menopausal women with moderate to severe endometriosis. [ Time Frame: 8 months (Assess PK profile from first dosing through end of study and compare PK on Day 1 of first dose to that of third month) ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: July 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGS649 high dose Drug: BGS649
Experimental: BGS649 low dose Drug: BGS649
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Premenopausal women with documented moderate to severe endometriosis. Occurrence of three sequential menstrual cycles of 24-35 days duration prior to enrollment.
  • Laparoscopically proven diagnosis of moderate to severe endometriosis (diagnosed within the past 10 years before screening).
  • Patients not planning to become pregnant within one year after the screening visit and willing to use two effective methods of non-hormonal, barrier birth control for the duration of the study or who are surgically sterile.
  • Patients must have a score of at least 4 on the numerical rating scale (NRS) for one of the following three pain measurements: pelvic pain, menstrual pain and dyspareunia

Exclusion Criteria:

  • Estrogen replacement therapy using either prescription medications or estrogen-containing OTC nutritional/herbal supplements such as soy extracts or topical estrogens.
  • Aromatase inhibitor therapy (includes Femara (letrozole), Aromasin (exemestane) or Arimidex (anastrozole) within the past 12 months.
  • Oral bisphosphonate therapy (i.e. Fosamax (alendronate)) within the past 6 months or intravenous bisphosphonate (i.e., Reclast, pamidronate) < 15 months from screening.
  • Systemic glucocorticoid therapy within the past 4 weeks.
  • Contra-indications to oral contraceptive use.

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: NCT01190475

Locations
United States, California
Novartis Investigative Site
Anaheim, California, United States, 92801
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01190475     History of Changes
Other Study ID Numbers: CBGS649A2105
Study First Received: August 19, 2010
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Endometriosis
Infertility
Pain
Vaginal Diseases
Uterine Diseases

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 23, 2014