BGS649 Monotherapy in Moderate to Severe Endometriosis Patients
Completed · Phase 2 · Has a placebo group
Conditions studied: Endometriosis
In brief
This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.
Key facts
- Study ID
- NCT01190475
- Run by
- Mereo BioPharma
- People needed
- 6
- Starts
- 2010-07-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2020-10-27
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Novartis Investigative Site — Anaheim, California, United States
Full record on ClinicalTrials.gov
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