BGS649 Monotherapy in Moderate to Severe Endometriosis Patients

NCT01190475 | Completed Phase 2 Results

• 1 other identifier: CBGS649A2105
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometriosis

Keywords

Endometriosis; Infertility; Pain; Vaginal Diseases; Uterine Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pharmacokinetic Profille of BGS649 as Described by AUC0-672h

  8 hours

• Pharmacokinetic Profile of BGS649 as Described by Cmax

  8 hours

• Pharmacokinetic Profile of BGS649 as Described by Tmax

  8 hours

Study Arms (3)

BGS649 high dose

EXPERIMENTAL

1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules.

Drug: Active treatment with a high dose of BGS649

BGS649 low dose

EXPERIMENTAL

1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules

Drug: Active treatment with a low dose of BGS649

Placebo to BGS649

PLACEBO COMPARATOR

1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules

Drug: Placebo treatment to blind study

Interventions

Active treatment with a high dose of BGS649 DRUG

BGS649 high dose

Active treatment with a low dose of BGS649 DRUG

BGS649 low dose

Placebo treatment to blind study DRUG

Placebo to BGS649

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Mereo BioPharma: lead
• Novartis: collaborator

Study Sites (1)

Novartis Investigative Site

Anaheim, California, 92801, United States

Location

MeSH Terms

Conditions

Endometriosis; Infertility; Pain; Vaginal Diseases; Uterine Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was prematurely terminated because the safety endpoint was reached after a total of 6 patients were randomized into one of the 3 treatment arms.

Results Point of Contact

• Title: Jacqueline Parkin
• Organization: Mereo BioPharma

enquiries@mereobiopharma.com

+44 333 0237300

Study Officials

• Jacqueline Parkin, PhD FRCP

  Mereo BioPharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 27, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 27, 2020
• Results First Posted: December 14, 2017

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)