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Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis

Primary Purpose

Adenomyosis

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Epelsiban
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenomyosis focused on measuring Heavy menstrual bleeding, Adenomyosis, Safety, Epelsiban, Tolerability, Proof of concept

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Eighteen to 55 years of age, inclusive
  • Pre-menopausal with a history of regular menstrual cycles every 21-35 days and without intermenstrual bleeding heavier than spotting and staining.
  • Females with adenomyosis confirmed on magnetic resonance imaging (MRI), - Females with heavy menstrual bleeding .
  • Willing and able to collect all menstrual cycle by-products for each cycle from screening to follow up.
  • Not pregnant as confirmed by a negative serum human chorionic gonadotropin

Exclusion Criteria:

  • A female subject will not be eligible for inclusion in this study if any of the following criteria apply:
  • Abnormal gynecological examination other than adenomyosis and/or breast examination requiring intervention within six months of study start
  • Abnormal endometrial biopsy within six months of starting study treatment.
  • History of an endometrial ablation within 12 months of starting study treatment.
  • Uterine artery embolization within six months of starting study treatment.
  • Prior major uterine procedures or any other significant uterine abnormalities on MRI (previous caesarean section, dilation and curettage, and diagnostic hysteroscopy are permitted).
  • Confirmed rectovaginal endometriosis in women who have undergone a prior laparoscopy.
  • Active pelvic infection or current use of an intrauterine device within three months of screening.
  • Women with a history of transfusion for heavy menstrual bleeding within the past 2 years or history of postpartum hemorrhage.
  • Any uterine dimension >20 centimeter (cm).
  • Other major causes of heavy menstrual bleeding -
  • Use within 3 months or anticipated use of medications that modify reproductive function
  • Use or anticipated use of the following drugs: anticoagulants aminocaproic acid ,or any other medications that affect menstrual bleeding such as tranexamic acid.
  • Use of daily opioid pain medications other than with menses.
  • Hemoglobin <8 grams (g)/deciliter.
  • History of bleeding disorder or known presence of acquired or inherited thrombophilia, (sickle cell trait individuals are not excluded).

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Epelsiban 75 mg

Epelsiban 200 mg

Placebo

Arm Description

Approximately 24 subjects will receive 75 mg of epelsiban three times a day (TID) via oral administration

Approximately 24 subjects will receive 200 mg of epelsiban TID via oral administration

Approximately 24 subjects will receive a matching placebo TID via oral administration

Outcomes

Primary Outcome Measures

Mean percent change from baseline in monthly menstrual blood loss (MBL) to menstrual Cycle 3
MBL will be measured from blood collected from menstrual cycle by-products and recovered by alkaline hematin method during each menstrual cycle
Number of subjects with adverse events (AE)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; safety and tolerability as assessed by incidence of adverse events

Secondary Outcome Measures

Change from baseline in monthly menstrual blood loss (MBL) at menstrual Cycle 1, 2, and 3
MBL will be measured from blood collected from menstrual cycle by-products
Average daily dysmenorrhea score from Day -1 to Day 2 in each cycle
Average daily dysmenorrhea score from Day -1 to Day 2 of menses

Full Information

First Posted
June 6, 2016
Last Updated
January 16, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT02794467
Brief Title
Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis
Official Title
A Phase II, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Proof of Concept Study With an Interim Futility Analysis of Epelsiban in Patients With Adenomyosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study was prematurely discontinued due to GSK's change in prioritization for the portfolio and is not due to any safety concerns or regulatory interaction.
Study Start Date
July 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of the study is to assess the efficacy, safety, and tolerability of epelsiban compared with placebo in treatment of women with adenomyosis. This is a 12-week, randomized, double-blind, placebo-controlled, parallel group study with an interim futility analysis. Subjects will be randomized 1:1:1 to receive 75 milligrams (mg) of epelsiban three times daily (TID), 200 mg of epelsiban TID, or placebo TID. The study will be composed of three periods: screening, treatment, and follow-up and the total time a subject will be in the study will be approximately 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomyosis
Keywords
Heavy menstrual bleeding, Adenomyosis, Safety, Epelsiban, Tolerability, Proof of concept

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epelsiban 75 mg
Arm Type
Experimental
Arm Description
Approximately 24 subjects will receive 75 mg of epelsiban three times a day (TID) via oral administration
Arm Title
Epelsiban 200 mg
Arm Type
Experimental
Arm Description
Approximately 24 subjects will receive 200 mg of epelsiban TID via oral administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Approximately 24 subjects will receive a matching placebo TID via oral administration
Intervention Type
Drug
Intervention Name(s)
Epelsiban
Intervention Description
Epelsiban will be supplied as modified capsule shaped, white coated, oral tablet with a unit dose strength of 25 or 150 mg; to be taken with food or immediately after a meal, without chewing
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A matching placebo will be supplied as modified capsule shaped, white coated, oral tablet; to be taken with food or immediately after a meal, without chewing.
Primary Outcome Measure Information:
Title
Mean percent change from baseline in monthly menstrual blood loss (MBL) to menstrual Cycle 3
Description
MBL will be measured from blood collected from menstrual cycle by-products and recovered by alkaline hematin method during each menstrual cycle
Time Frame
Baseline and end of menses Cycle 3 (approximately 12 weeks)
Title
Number of subjects with adverse events (AE)
Description
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; safety and tolerability as assessed by incidence of adverse events
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Change from baseline in monthly menstrual blood loss (MBL) at menstrual Cycle 1, 2, and 3
Description
MBL will be measured from blood collected from menstrual cycle by-products
Time Frame
Baseline, and end of menses Cycle 1, 2, and 3 (approximately 12 weeks)
Title
Average daily dysmenorrhea score from Day -1 to Day 2 in each cycle
Description
Average daily dysmenorrhea score from Day -1 to Day 2 of menses
Time Frame
Up to 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eighteen to 55 years of age, inclusive Pre-menopausal with a history of regular menstrual cycles every 21-35 days and without intermenstrual bleeding heavier than spotting and staining. Females with adenomyosis confirmed on magnetic resonance imaging (MRI), - Females with heavy menstrual bleeding . Willing and able to collect all menstrual cycle by-products for each cycle from screening to follow up. Not pregnant as confirmed by a negative serum human chorionic gonadotropin Exclusion Criteria: A female subject will not be eligible for inclusion in this study if any of the following criteria apply: Abnormal gynecological examination other than adenomyosis and/or breast examination requiring intervention within six months of study start Abnormal endometrial biopsy within six months of starting study treatment. History of an endometrial ablation within 12 months of starting study treatment. Uterine artery embolization within six months of starting study treatment. Prior major uterine procedures or any other significant uterine abnormalities on MRI (previous caesarean section, dilation and curettage, and diagnostic hysteroscopy are permitted). Confirmed rectovaginal endometriosis in women who have undergone a prior laparoscopy. Active pelvic infection or current use of an intrauterine device within three months of screening. Women with a history of transfusion for heavy menstrual bleeding within the past 2 years or history of postpartum hemorrhage. Any uterine dimension >20 centimeter (cm). Other major causes of heavy menstrual bleeding - Use within 3 months or anticipated use of medications that modify reproductive function Use or anticipated use of the following drugs: anticoagulants aminocaproic acid ,or any other medications that affect menstrual bleeding such as tranexamic acid. Use of daily opioid pain medications other than with menses. Hemoglobin <8 grams (g)/deciliter. History of bleeding disorder or known presence of acquired or inherited thrombophilia, (sickle cell trait individuals are not excluded).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Washington, DC
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
GSK Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
GSK Investigational Site
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
GSK Investigational Site
City
Mandeville
State/Province
Louisiana
ZIP/Postal Code
70471
Country
United States
Facility Name
GSK Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
GSK Investigational Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
GSK Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
GSK Investigational Site
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
GSK Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
GSK Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
GSK Investigational Site
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Facility Name
GSK Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis

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