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Completed

NCT Number: NCT03070951

Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids

The primary objective of this study is 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.

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Key information

Conditions

Uterine Fibroids Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Heavy Menstrual Bleeding Hemorrhage Leiomyoma Menorrhagia Menstruation Disturbances Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Site reference ID 265, Gabrovo, Bulgaria

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About this study

The study is a prospective, randomized, parallel group, double-blind, placebo-controlled phase 3 study investigating the efficacy and safety of OBE2109 alone and in combination with add-back therapy for the treatment of uterine fibroids.

Subjects will be randomized to one of 5 treatment groups in a 1:1:1:1:1 ratio.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Premenopausal woman at screening.
  • Body Mass Index ≥ 18 kg/m2.
  • Menstrual cycles ≥ 21 days and ≤ 40 days.
  • Presence of uterine fibroids.
  • Heavy menstrual blood loss for each of the 2 menstrual periods assessed at screening using the alkaline hematin method.

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.
  • 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.

Treatment and study plan

OBE2109

Drug

OBE2109 100mg tablets for oral administration once daily

Placebo to match OBE2109

Drug

Placebo to match OBE2109 100mg tablets for oral administration once daily

Placebo to match Add-back

Drug

Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily

Add-back

Drug

Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily

Primary outcomes

  1. Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24

    Time frame: From baseline to Week 24

    Assessed using the alkaline hematin method

Secondary outcomes

  1. Time to reduced menstrual blood loss

    Time frame: Up to Week 52

    Assessed using the alkaline hematin method

  2. Amenorrhea

    Time frame: Up to Week 52

    Assessed using the alkaline hematin method

  3. Time to amenorrhea

    Time frame: Up to Week 52

  4. Number of days of uterine bleeding for the last 28-day interval prior to Week 24

    Time frame: last 28-day interval prior to Week 24

    Assessed using the alkaline hematin method

  5. Number of days of uterine bleeding for each 28-day interval

    Time frame: Up to Week 52

    Assessed using the alkaline hematin method

Other outcomes

  1. Bone Mineral Density (BMD)

    Time frame: From baseline up to Week 76

    Assessed by dual-energy X-ray absorptiometry (DXA) scan

  2. Endometrial biopsy

    Time frame: From baseline up to Week 52

    Assessed by histology

  3. Adverse events

    Time frame: Up to Week 76

    Frequency and severity of Treatment-Emergent Adverse Events

Sponsors and collaborators

Lead sponsor

ObsEva SA

Industry

Registry information

Official study 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

Acronym: PRIMROSE 2

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 6, 2017
Registry last updated
Mar 5, 2021

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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