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BGS649 Monotherapy in Moderate to Severe Endometriosis Patients

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.
ClinicalTrials.gov Identifier: NCT01190475
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: BGS649 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2010
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: BGS649 high dose Drug: BGS649
Experimental: BGS649 low dose Drug: BGS649
Placebo Comparator: Placebo Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger [ Time Frame: 8 months ]
    Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger.


Secondary Outcome Measures :
  1. 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) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

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 ClinicalTrials.gov identifier (NCT number): NCT01190475


Locations
United States, California
Novartis Investigative Site
Anaheim, California, United States, 92801
Sponsors and Collaborators
Mereo BioPharma
Novartis
Investigators
Study Director: Jacqueline Parkin, PhD FRCP Mereo BioPharma
More Information

Responsible Party: Mereo BioPharma
ClinicalTrials.gov Identifier: NCT01190475     History of Changes
Other Study ID Numbers: CBGS649A2105
First Posted: August 27, 2010    Key Record Dates
Results First Posted: December 14, 2017
Last Update Posted: December 14, 2017
Last Verified: September 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mereo BioPharma:
Endometriosis
Infertility
Pain
Vaginal Diseases
Uterine Diseases

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female