ClinicalTrials.Veeva

Menu

BGS649 Monotherapy in Moderate to Severe Endometriosis Patients

M

Mereo BioPharma

Status and phase

Completed
Phase 2

Conditions

Endometriosis

Treatments

Drug: Active treatment with a high dose of BGS649
Drug: Active treatment with a low dose of BGS649
Drug: Placebo treatment to blind study

Study type

Interventional

Funder types

Industry

Identifiers

NCT01190475
CBGS649A2105

Details and patient eligibility

About

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

Enrollment

6 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

6 participants in 3 patient groups, including a placebo group

BGS649 high dose
Experimental group
Description:
1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules.
Treatment:
Drug: Active treatment with a high dose of BGS649
BGS649 low dose
Experimental group
Description:
1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules
Treatment:
Drug: Active treatment with a low dose of BGS649
Placebo to BGS649
Placebo Comparator group
Description:
1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules
Treatment:
Drug: Placebo treatment to blind study

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems