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Completed

NCT Number: NCT01190475

BGS649 Monotherapy in Moderate to Severe Endometriosis Patients

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

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Uterine Diseases Vaginal Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active treatment with a high dose of BGS649

Drug

Active treatment with a low dose of BGS649

Drug

Placebo treatment to blind study

Drug

Primary outcomes

  1. Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger

    Time frame: 8 months

    Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger.

Secondary outcomes

  1. Pharmacokinetic Profille of BGS649 as Described by AUC0-672h

    Time frame: 8 hours

    AUC0-672 is a measurement of how much drug reaches a person's bloodstream in a given period of time after a dose is given. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occured at pre-dose, 0.5-1.5h and 4-8 h post-dose.

  2. Pharmacokinetic Profile of BGS649 as Described by Cmax

    Time frame: 8 hours

    The peak plasma concentration of BGS649 after dosing at cycle 2 and cycle 4. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occured at pre-dose, 0.5-1.5h and 4-8 h post-dose.

  3. Pharmacokinetic Profile of BGS649 as Described by Tmax

    Time frame: 8 hours

    Time taken to reach the maximum concentration in plasma of BGS649 at cycle 2 and cycle 4. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occurred at pre-dose, 0.5-1.5h and 4-8 h post-dose.

Sponsors and collaborators

Lead sponsor

Mereo BioPharma

Industry

Collaborators

  • Novartis

Registry information

Official study title

A Randomized, Double-blind, Double-dummy, Placebo-controlled Study of Oral BGS649 Monotherapy Assessing Safety and Tolerability in Patients With Moderate to Severe Endometriosis

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 27, 2010
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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