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A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis (EDELWEISS)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02778399
First Posted: May 19, 2016
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ObsEva SA
  Purpose
The primary objective of this study is to assess the efficacy and safety of a range of oral doses of OBE2109 versus placebo, in reducing endometriosis associated pain.

Condition Intervention Phase
Endometriosis Drug: Placebo Drug: OBE2109 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 2b Dose-ranging Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis Associated Pain

Resource links provided by NLM:


Further study details as provided by ObsEva SA:

Primary Outcome Measures:
  • Endometriosis associated pelvic pain score [ Time Frame: From baseline to week 12 ]

Secondary Outcome Measures:
  • Endometriosis associated pelvic pain scores [ Time Frame: From baseline up to week 36 ]
  • Endometriosis associated pelvic pain scores for days with uterine bleeding [ Time Frame: From baseline up to week 36 ]
  • Endometriosis associated pelvic pain scores for days with no uterine bleeding [ Time Frame: From baseline up to week 36 ]
  • Dyspareunia score [ Time Frame: Up to week 36 ]
  • Dyschezia score [ Time Frame: Up to week 36 ]
  • Use of analgesics [ Time Frame: Up to week 36 ]
  • Endometriosis Health Profile-30 (EHP-30) score [ Time Frame: Up to week 36 ]
  • Patient Global Impression of Change (PGIC) score [ Time Frame: Up to week 36 ]
  • Patient status score [ Time Frame: Up to week 36 ]
  • Modified Biberoglu & Behrman (mB&B) score [ Time Frame: Up to week 36 ]
    The severity of subject reported pain symptoms of endometriosis and physician findings of endometriosis according to the mB&B scale.

  • Difficulty in doing daily activities score [ Time Frame: Up to week 36 ]
  • Bone Mineral Density (BMD) [ Time Frame: From baseline up to week 48 ]
    Change from baseline up to week 48 in BMD assessed by dual-energy X-ray absorptiometry (DXA) scan.

  • Endometrial biopsies [ Time Frame: From baseline up to week 36 ]
    Any pathological changes from baseline in the endometrium assessed by histology from endometrial biopsies.

  • Transvaginal ultrasound (TVUS) endometrial thickness [ Time Frame: From baseline up to week 36 ]
    Any pathological changes from baseline in the endometrium.

  • Adverse events [ Time Frame: Up to week 48. ]
    Treatment emergent adverse events frequency and severity.

  • Clinical laboratory assessments and vital signs [ Time Frame: From baseline up to week 36 ]
    Change from baseline in clinical laboratory assessments and vital signs.


Estimated Enrollment: 330
Actual Study Start Date: July 2016
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OBE2109 dose 1 Drug: OBE2109
OBE2109 tablets for oral administration once daily
Experimental: OBE2109 dose 2 Drug: OBE2109
OBE2109 tablets for oral administration once daily
Experimental: OBE2109 dose 3 Drug: OBE2109
OBE2109 tablets for oral administration once daily
Experimental: OBE2109 dose 4 Drug: OBE2109
OBE2109 tablets for oral administration once daily
Experimental: OBE2109 dose 5 Drug: OBE2109
OBE2109 tablets for oral administration once daily
Placebo Comparator: Placebo / OBE2109 dose 6 Drug: Placebo
Placebo tablets for oral administration once daily
Drug: OBE2109
OBE2109 tablets for oral administration once daily

Detailed Description:

The study is a prospective, dose-finding, randomized, parallel group, double-blind, placebo-controlled phase 2b study investigating the efficacy and safety of OBE2109 in the treatment of 330 women with moderate-to-severe endometriosis associated pain.

Subject will be randomized to one of 6 treatment groups in a 1:1:1:1:1:1 ratio (1 placebo group, 5 dose groups with different dosage/regimen).

Eligible subjects will be offered the opportunity to continue treatment with OBE2109 in an extension phase. Subjects who do not continue in the extension will enter the treatment-free follow-up phase of the study.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • The subject must have had her most recent surgical and - if available - histological, diagnosis of pelvic endometriosis up to 10 years before screening.
  • The subject has moderate to severe endometriosis-associated pain during the screening period.
  • The subject has regular menstrual cycles.
  • The subject has a BMI ≥ 18 kg/m2 at the screening visit.

Key Exclusion Criteria:

  • The subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
  • The subject had an interventional surgery for endometriosis performed within a period of 60 days before screening.
  • The subject did not respond to prior treatment with gonadotropin releasing hormone (GnRH) agonists or GnRH antagonists for endometriosis.
  • The subject has a history of, or known osteoporosis or other metabolic bone disease.
  • The subject has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic / therapy, or that would interfere with the assessment of endometriosis related pain.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778399


  Show 86 Study Locations
Sponsors and Collaborators
ObsEva SA
Investigators
Study Director: ObsEva SA Geneva
  More Information

Responsible Party: ObsEva SA
ClinicalTrials.gov Identifier: NCT02778399     History of Changes
Other Study ID Numbers: 15-OBE2109-001
First Submitted: May 3, 2016
First Posted: May 19, 2016
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by ObsEva SA:
Pelvic Pain
Endometriosis
Dysmenorrhea
Dyspareunia

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female