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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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.
- 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.
- 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.
- 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.
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
|United States, California|
|Novartis Investigative Site|
|Anaheim, California, United States, 92801|
|Study Director:||Jacqueline Parkin, PhD FRCP||Mereo BioPharma|