Back to resultsBGS649 Monotherapy in Moderate to Severe Endometriosis Patients
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Active treatment with a high dose of BGS649
Active treatment with a low dose of BGS649
Placebo treatment to blind study
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring Endometriosis, Infertility, Pain, Vaginal Diseases, Uterine Diseases
Eligibility 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
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
BGS649 high dose
BGS649 low dose
Placebo to BGS649
Arm Description
1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules.
1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules
1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules
Outcomes
Primary Outcome Measures
Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger
Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger.
Secondary Outcome Measures
Pharmacokinetic Profille of BGS649 as Described by AUC0-672h
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.
Pharmacokinetic Profile of BGS649 as Described by Cmax
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.
Pharmacokinetic Profile of BGS649 as Described by Tmax
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.
Full Information
NCT ID
NCT01190475
First Posted
August 19, 2010
Last Updated
October 5, 2020
Sponsor
Mereo BioPharma
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT01190475
Brief Title
BGS649 Monotherapy in Moderate to Severe Endometriosis Patients
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 Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mereo BioPharma
Collaborators
Novartis
4. Oversight
5. Study Description
Brief Summary
This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis, Infertility, Pain, Vaginal Diseases, Uterine Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BGS649 high dose
Arm Type
Experimental
Arm Description
1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules.
Arm Title
BGS649 low dose
Arm Type
Experimental
Arm Description
1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules
Arm Title
Placebo to BGS649
Arm Type
Placebo Comparator
Arm Description
1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules
Intervention Type
Drug
Intervention Name(s)
Active treatment with a high dose of BGS649
Intervention Type
Drug
Intervention Name(s)
Active treatment with a low dose of BGS649
Intervention Type
Drug
Intervention Name(s)
Placebo treatment to blind study
Primary Outcome Measure Information:
Title
Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger
Description
Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Pharmacokinetic Profille of BGS649 as Described by AUC0-672h
Description
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.
Time Frame
8 hours
Title
Pharmacokinetic Profile of BGS649 as Described by Cmax
Description
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.
Time Frame
8 hours
Title
Pharmacokinetic Profile of BGS649 as Described by Tmax
Description
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.
Time Frame
8 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline Parkin, PhD FRCP
Organizational Affiliation
Mereo BioPharma
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BGS649 Monotherapy in Moderate to Severe Endometriosis Patients
We'll reach out to this number within 24 hrs