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BGS649 Monotherapy in Moderate to Severe Endometriosis Patients

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ClinicalTrials.gov Identifier: NCT01190475
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : December 14, 2017
Last Update Posted : October 27, 2020
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Mereo BioPharma

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: Active treatment with a high dose of BGS649 Drug: Active treatment with a low dose of BGS649 Drug: Placebo treatment to blind study Phase 2

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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
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: BGS649 high dose
1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules.
Drug: Active treatment with a high dose of BGS649
Experimental: BGS649 low dose
1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules
Drug: Active treatment with a low dose of BGS649
Placebo Comparator: Placebo to BGS649
1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules
Drug: Placebo treatment to blind study



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. Pharmacokinetic Profille of BGS649 as Described by AUC0-672h [ Time Frame: 8 hours ]
    AUC0-672 is a measurement of how much drug reaches a person's bloodstream in a given period of time after a dose is given. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occured at pre-dose, 0.5-1.5h and 4-8 h post-dose.

  2. Pharmacokinetic Profile of BGS649 as Described by Cmax [ Time Frame: 8 hours ]
    The peak plasma concentration of BGS649 after dosing at cycle 2 and cycle 4. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occured at pre-dose, 0.5-1.5h and 4-8 h post-dose.

  3. Pharmacokinetic Profile of BGS649 as Described by Tmax [ Time Frame: 8 hours ]
    Time taken to reach the maximum concentration in plasma of BGS649 at cycle 2 and cycle 4. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occurred at pre-dose, 0.5-1.5h and 4-8 h post-dose.



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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


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
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United States, California
Novartis Investigative Site
Anaheim, California, United States, 92801
Sponsors and Collaborators
Mereo BioPharma
Novartis
Investigators
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Study Director: Jacqueline Parkin, PhD FRCP Mereo BioPharma
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Responsible Party: Mereo BioPharma
ClinicalTrials.gov Identifier: NCT01190475    
Other Study ID Numbers: CBGS649A2105
First Posted: August 27, 2010    Key Record Dates
Results First Posted: December 14, 2017
Last Update Posted: October 27, 2020
Last Verified: October 2020
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:
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Endometriosis