BGS649 Monotherapy in Moderate to Severe Endometriosis Patients

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190475
• Other study ID #: CBGS649A2105
• Status: Completed
• Phase: Phase 2
• Start date: July 2010
• Est. completion date: September 2011

Study information

• Verified date: October 2020
• Source: Mereo BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Active treatment with a high dose of BGS649

• Active treatment with a low dose of BGS649

• Placebo treatment to blind study

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Anaheim	California

Sponsors (2)

Lead Sponsor	Collaborator
Mereo BioPharma	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 months
Secondary	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.	8 hours
Secondary	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.	8 hours
Secondary	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.	8 hours