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
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 April 16, 2014