Phase 2
N=6
BGS649 Monotherapy in Moderate to Severe Endometriosis Patients
Endometriosis
Bottom Line
View on ClinicalTrials.gov: NCT01190475 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger — 2; 2; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Active treatment with a high dose of BGS649 (Drug); Active treatment with a low dose of BGS649 (Drug); Placebo treatment to blind study (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Mereo BioPharma
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger |
2; 2; 0 | — |
| SECONDARY Pharmacokinetic Profille of BGS649 as Described by AUC0-672h |
2557; 443.8; 3283; 639.6 | — |
| SECONDARY Pharmacokinetic Profile of BGS649 as Described by Cmax |
9.040; 2.720; 15.25; 3.410 | — |
| SECONDARY Pharmacokinetic Profile of BGS649 as Described by Tmax |
1.00; 1.00; 1.00; 1.00 | — |
Summary
This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01190475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.