Status:
COMPLETED
BGS649 Monotherapy in Moderate to Severe Endometriosis Patients
Lead Sponsor:
Mereo BioPharma
Collaborating Sponsors:
Novartis
Conditions:
Endometriosis
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
Brief Summary
This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01190475
Start Date
July 1 2010
End Date
September 1 2011
Last Update
October 27 2020
Active Locations (1)
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1
Novartis Investigative Site
Anaheim, California, United States, 92801