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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
BGS649 High Dose BGS649
BGS649 Low Dose BGS649
Placebo Placebo

Participant Flow:   Overall Study
    BGS649 High Dose   BGS649 Low Dose   Placebo
STARTED   2   2   2 
COMPLETED   2   2   1 
NOT COMPLETED   0   0   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BGS649 High Dose BGS649
BGS649 Low Dose BGS649
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
   BGS649 High Dose   BGS649 Low Dose   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   2   2   6 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Full Range)
 30 
 (21 to 39) 
 28 
 (28 to 28) 
 30.5 
 (30 to 31) 
 29 
 (21 to 39) 
Sex: Female, Male 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
       
Caucasian   1   2   2   5 
Black   1   0   0   1 
Region of Enrollment 
[Units: Participants]
       
United States   2   2   2   6 


  Outcome Measures

1.  Primary:   Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger   [ Time Frame: 8 months ]

2.  Secondary:   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) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Ian Hodgson
Organization: Mereo BioPharma
phone: +44 333 0237300
e-mail: enquiries@mereobiopharma.com



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