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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:
Novartis
Information provided by (Responsible Party):
Mereo BioPharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Endometriosis
Interventions Drug: BGS649
Drug: Placebo
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BGS649 High Dose BGS649 Low Dose Placebo
Hide Arm/Group Description BGS649 BGS649 Placebo
Period Title: Overall Study
Started 2 2 2
Completed 2 2 1
Not Completed 0 0 1
Arm/Group Title BGS649 High Dose BGS649 Low Dose Placebo Total
Hide Arm/Group Description BGS649 BGS649 Placebo Total of all reporting groups
Overall Number of Baseline Participants 2 2 2 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 2 participants 6 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
2
 100.0%
2
 100.0%
6
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants 2 participants 2 participants 6 participants
30
(21 to 39)
28
(28 to 28)
30.5
(30 to 31)
29
(21 to 39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 2 participants 6 participants
Female
2
 100.0%
2
 100.0%
2
 100.0%
6
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 2 participants 6 participants
Caucasian
1
  50.0%
2
 100.0%
2
 100.0%
5
  83.3%
Black
1
  50.0%
0
   0.0%
0
   0.0%
1
  16.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 2 participants 2 participants 6 participants
2 2 2 6
1.Primary Outcome
Title Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger
Hide Description Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger.
Time Frame 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger
Arm/Group Title BGS649 High Dose BGS649 Low Dose Placebo
Hide Arm/Group Description:
BGS649
BGS649
Placebo
Overall Number of Participants Analyzed 2 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
2
 100.0%
0
   0.0%
2.Secondary Outcome
Title 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.
Hide Description [Not Specified]
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)
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BGS649 High Dose BGS649 Low Dose Placebo
Hide Arm/Group Description BGS649 BGS649 Placebo
All-Cause Mortality
BGS649 High Dose BGS649 Low Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
BGS649 High Dose BGS649 Low Dose Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/2 (0.00%)      0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BGS649 High Dose BGS649 Low Dose Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      2/2 (100.00%)      2/2 (100.00%)    
Gastrointestinal disorders       
Abdominal pain   0/2 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Nausea   1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0
Nervous system disorders       
Headache   0/2 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1
Reproductive system and breast disorders       
Menorrhagia   0/2 (0.00%)  0 1/2 (50.00%)  1 0/2 (0.00%)  0
Metrorrhagia   1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Bronchitis   0/2 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1
Upper respiratory tract infection   1/2 (50.00%)  1 0/2 (0.00%)  0 0/2 (0.00%)  0
Skin and subcutaneous tissue disorders       
Acne   0/2 (0.00%)  0 0/2 (0.00%)  0 1/2 (50.00%)  1
Indicates events were collected by systematic assessment
The study was prematurely terminated because the safety endpoint was reached after a total of 6 patients were randomized into one of the 3 treatment arms.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
All PIs must seek written permission from the sponsor prior to publication of any trial results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ian Hodgson
Organization: Mereo BioPharma
Phone: +44 333 0237300
EMail: enquiries@mereobiopharma.com
Layout table for additonal information
Responsible Party: Mereo BioPharma
ClinicalTrials.gov Identifier: NCT01190475     History of Changes
Other Study ID Numbers: CBGS649A2105
First Submitted: August 19, 2010
First Posted: August 27, 2010
Results First Submitted: November 16, 2017
Results First Posted: December 14, 2017
Last Update Posted: December 14, 2017