A phase 3 study of OBE2109 in subjects with heavy menstrual bleeding associated with uterine fibroids.

• Register: EUCTR
• Last refreshed on: 5 January 2021
• Main ID: EUCTR2016-004059-53-LV
• Date of registration: 18/04/2017
• Prospective Registration: Yes
• Primary sponsor: ObsEva SA
• Public title: A phase 3 study of OBE2109 in subjects with heavy menstrual bleeding associated with uterine fibroids.
• Scientific title: A Phase 3, multicentre, randomized, double-blind, placebo controlled study investigating the efficacy and safety of daily oral administration of OBE2109 alone and in combination with add-back therapy for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. - Primrose 2
• Date of first enrolment: 22/06/2017
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004059-53
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Czech Republic, Hungary, Latvia, Lithuania, Poland, Romania, Ukraine, United States

Contacts

• Name: Clinical Trial Information
• Affiliation: ObsEva SA

• Name: Clinical Trial Information
• Affiliation: ObsEva SA

Key inclusion & exclusion criteria

Inclusion criteria:
• Premenopausal woman at screening
• Body Mass Index = 18 kg/m2
• Menstrual cycles = 21 days and = 40 days prior to screening
• Presence of uterine fibroids
• Heavy menstrual blood loss for the first eight days of two menstrual periods assessed at screening using the alkaline hematin method
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the study
• History of uterus surgery that would interfere with the study
• The subject’s condition is so severe that she will require surgery within 6 months regardless of the treatment provided
• Undiagnosed abnormal uterine bleeding
• Significant risk of osteoporosis or history of, or known osteoporosis or other metabolic bone disease


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Treatment of heavy menstrual bleeding associated with uterine fibroids.
MedDRA version: 20.0 Level: LLT Classification code 10046784 Term: Uterine fibroids System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Intervention(s)

Product Name: OBE2109
Product Code: OBE2109
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: NA
Current Sponsor code: OBE2109
Other descriptive name: OBE2109
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Kliovance 1 mg/0.5 mg film-coated tablets
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ESTRADIOL HEMIHYDRATE
CAS Number: 35380-71-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: NORETHISTERONE ACETATE
CAS Number: 51-98-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Reduced menstrual blood loss at 24 weeks of treatment (last 28 days prior to Week 24 visit) defined as menstrual blood loss = 80 mL and = 50% reduction from baseline.

Secondary Objective: Efficacy:
To demonstrate the superior efficacy of 24 weeks of OBE2109 alone and in combination with add-back therapy versus placebo on:
- Incidence of amenorrhea and time to amenorrhea
- Hemoglobin levels
- Menstrual bleeding

To evaluate the effect of 24 weeks of OBE2109 alone and in combination with add-back therapy versus placebo on:
- Pain
- Uterine fibroid symptom severity and health-related quality of life
- Uterus volume
- Myoma volume

To evaluate the effect of 52 weeks of OBE2109 alone and in combination with add-back therapy on the above-listed assessments.

To evaluate the impact of submucosal fibroids on primary efficacy endpoint.

Main Objective: Efficacy objective: To demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Safety objectives:
- To assess the effect of OBE2109 alone and in combination with add-back therapy versus placebo on bone mineral density.
- To assess the overall safety of OBE2109 alone and in combination with add-back therapy in subjects with uterine fibroids.

Timepoint(s) of evaluation of this end point: Week 24

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. Up to Weeks 24 and 52
2. Up to Weeks 24 and 52
3. Up to Weeks 24 and 52
4. Up to Week 52
5. Weeks 12, 24, 36, 52, 64
6. Weeks 24, 52, 76
7. Weeks 24, 52
8. Up to Week 64
9. Up to Week 76
10. From baseline up to Week 64

Secondary end point(s): 1. Amenorrhea assessed using the alkaline hematin method
2. Time to amenorrhea
3. Time to reduced menstrual blood loss assessed using the alkaline hematin method
4. Number of days of uterine bleeding for each 28-day interval assessed using the alkaline hematin method
5. Hemoglobin levels (Laboratory assessment)
6. Bone Mineral Density (BMD) assessed by dual-energy X-ray absorptiometry (DXA) scan
7. Endometrial biopsy assessed by histology
8. Endometrial thickness (assessed by ultrasound)
9. Adverse events -Frequency and severity of Treatment-Emergent Adverse Events
10. Clinical laboratory assessments and vital signs -clinically significant changes from baseline in clinical laboratory assessments and vital signs

Secondary ID(s)

16-OBE2109-009

2016-004059-53-HU

Source(s) of Monetary Support

ObsEva SA

Ethics review

Status: Approved
Approval date: 20/04/2017
Contact: