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Study to Evaluate the Safety and Efficacy of RAD1901 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms

Primary Purpose

Vasomotor Symptoms, Hot Flashes

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RAD1901
Placebo
Sponsored by
Radius Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasomotor Symptoms

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

To have participated in this study, a subject MUST:

  1. be a postmenopausal woman between 40 and 65 years of age, inclusive
  2. be seeking relief or treatment for moderate to severe VMS
  3. be willing to discontinue and abstain from the following: vaginal hormonal products; transdermal or oral estrogen or estrogen/progestin combination; progestin implants; injectable estrogen; topical progesterone cream, selective estrogen receptor modulators and intrauterine devices (IUDs)
  4. have no clinically significant abnormalities on pelvic exam except for vulvovaginal atrophy (VVA)
  5. have a normal or clinically insignificant transvaginal ultrasound (TVU) with an endometrial thickness <4 mm at screening
  6. have a normal endometrial biopsy subsequent to the TVU without clinically relevant results
  7. have a normal screening Papanicolaou (Pap) smear
  8. have a mammogram within 9 months prior to randomization. Subjects must have had a Breast Imaging Reporting and Data System (BI-RADS) mammography result of 1 or 2 to enroll.

Exclusion Criteria:

Subjects with any of the following characteristics were not be eligible to participate in the study:

  1. have a history of invasive breast cancer or ductal carcinoma in situ, melanoma or any gynecologic cancer.

  2. using any of the following:

    • oral estrogen-, progestin-, androgen-, or selective estrogen receptor modulator (SERM) containing drug products within 8 weeks before screening (visit 1)
    • transdermal hormone products within 4 weeks before screening (visit 1)
    • vaginal hormone products (rings, creams, gels) within 4 weeks before screening (visit 1)
    • progestin implants/injectables, IUDs or estrogen pellets/injectables within 6 months before screening (visit 1)
    • anabolic steroids
  3. have been treated with a gonadotropin-releasing hormone (GnRH) agonist within the last year
  4. have been treated with anti-estrogens or aromatase inhibitors within 2 months prior to study entry
  5. have been concurrently treated and will abstain from gabapentin and paroxetine or serotonin and norepinephrine reuptake inhibitors (SNRIs) for VMS or other indications for 3 months during the trial and have not taken within 4 weeks prior to screening
  6. have unexplained vaginal bleeding within the 3 months prior to study entry
  7. have an endometrial biopsy at baseline with a diagnosis by a gynecologic pathologist of proliferative, hyperplasia, polyp or cancer
  8. have unresolved cervical cytological smear report of atypical glandular or squamous cells of undetermined significance. Cervical cytologic smear report of ASCUS, low grade squamous intraepithelial lesion or greater, or any reported dysplasia
  9. have unresolved findings suspicious for malignancy on the breast examination

Sites / Locations

  • Women's Health Care Specialists P.C. - Beyer Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Regimen 1

Regimen 2

Regimen 3

Regimen 4

Arm Description

RAD1901 5 mg/day

RAD1901 10 mg/day

RAD1901 20 mg/day

Placebo

Outcomes

Primary Outcome Measures

Change From Baseline to Week 12 in the Frequency of Moderate to Severe Hot Flashes
Change from baseline to week 12 in the average number of moderate and severe hot flashes per day, where change is calculated as week 12 minus baseline so that negative values indicate a reduction (improvement) of hot flash frequency. Severity of hot flashes was self-assessed and reported as follows: Mild: sensation of heat without sweating Moderate: sensation of heat with sweating, able to continue activity Severe: sensation of heat with sweating, causing cessation of activity.

Secondary Outcome Measures

Change From Baseline to Week 4 in the Frequency of Moderate to Severe Hot Flashes
Change from baseline to week 4 in the average number of moderate and severe hot flashes per day, where change is calculated as week 4 minus baseline so that negative values indicate a reduction (improvement) of hot flash frequency.
Change From Baseline to Week 4 and Week 12 in the Severity of Hot Flashes
Change from baseline to week 4 and week 12 in the average daily severity of hot flashes, where change is calculated as week 4 or week 12 minus baseline so that negative values indicate a reduction (improvement) of hot flash severity. Subjects recorded the number of hot flashes per day using an electronic diary. Daily severity score for hot flashes for each subject was calculated as the sum of the number of mild hot flashes, plus 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of mild, moderate, and severe hot flashes. That is, Daily Severity Score = (Fmild + 2•Fmod + 3•Fsev)/(Fmild + Fmod + Fsev) where Fmild= frequency of mild hot flashes, Fmod = frequency of moderate hot flashes, Fsev = frequency of severe hot flashes. The measure is a weighted average of the frequencies of Hot Flashes.
Change From Baseline to Week 4 and Week 12 in the Frequency of All Hot Flashes
Change from baseline to week 4 and week 12 in the average number of all hot flashes (mild, moderate, and severe) by eDiary, where change is calculated as week 4 or week 12 minus baseline so that negative values indicate a reduction (improvement) of hot flash frequency.

Full Information

First Posted
January 8, 2016
Last Updated
March 12, 2019
Sponsor
Radius Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02653417
Brief Title
Study to Evaluate the Safety and Efficacy of RAD1901 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety and Efficacy of RAD1901 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's Decision
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 12, 2016 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radius Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study was to determine the clinical safety of RAD1901 and to evaluate whether RAD1901 reduced the frequency and severity of moderate to severe vasomotor symptoms (VMS; "hot flashes") in postmenopausal women.
Detailed Description
This was a Phase 2b outpatient, prospective, multicenter, double-blind, randomized, placebo-controlled study to determine whether elacestrant reduces the frequency and severity of vasomotor symptoms (VMS; "hot flashes") in postmenopausal women with moderate to severe hot flashes. Postmenopausal women who met study criteria were followed for 12 weeks on double-blind study medication and two weeks off study medication. Treatment was randomized 1:1:1:1 to ensure that an approximately equal number of patients were exposed to each of three RAD1901 (elacestrant) doses (5, 10 and 20 mg/day) or placebo. The total period of placebo exposure was 14 weeks. Enrolling approximately 300 patients was expected to provide power for testing superiority of the primary efficacy endpoint outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasomotor Symptoms, Hot Flashes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regimen 1
Arm Type
Experimental
Arm Description
RAD1901 5 mg/day
Arm Title
Regimen 2
Arm Type
Experimental
Arm Description
RAD1901 10 mg/day
Arm Title
Regimen 3
Arm Type
Experimental
Arm Description
RAD1901 20 mg/day
Arm Title
Regimen 4
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
RAD1901
Other Intervention Name(s)
Elacestrant
Intervention Description
RAD1901
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline to Week 12 in the Frequency of Moderate to Severe Hot Flashes
Description
Change from baseline to week 12 in the average number of moderate and severe hot flashes per day, where change is calculated as week 12 minus baseline so that negative values indicate a reduction (improvement) of hot flash frequency. Severity of hot flashes was self-assessed and reported as follows: Mild: sensation of heat without sweating Moderate: sensation of heat with sweating, able to continue activity Severe: sensation of heat with sweating, causing cessation of activity.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 4 in the Frequency of Moderate to Severe Hot Flashes
Description
Change from baseline to week 4 in the average number of moderate and severe hot flashes per day, where change is calculated as week 4 minus baseline so that negative values indicate a reduction (improvement) of hot flash frequency.
Time Frame
Baseline and 4 weeks
Title
Change From Baseline to Week 4 and Week 12 in the Severity of Hot Flashes
Description
Change from baseline to week 4 and week 12 in the average daily severity of hot flashes, where change is calculated as week 4 or week 12 minus baseline so that negative values indicate a reduction (improvement) of hot flash severity. Subjects recorded the number of hot flashes per day using an electronic diary. Daily severity score for hot flashes for each subject was calculated as the sum of the number of mild hot flashes, plus 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of mild, moderate, and severe hot flashes. That is, Daily Severity Score = (Fmild + 2•Fmod + 3•Fsev)/(Fmild + Fmod + Fsev) where Fmild= frequency of mild hot flashes, Fmod = frequency of moderate hot flashes, Fsev = frequency of severe hot flashes. The measure is a weighted average of the frequencies of Hot Flashes.
Time Frame
Baseline, 4 weeks, and 12 weeks
Title
Change From Baseline to Week 4 and Week 12 in the Frequency of All Hot Flashes
Description
Change from baseline to week 4 and week 12 in the average number of all hot flashes (mild, moderate, and severe) by eDiary, where change is calculated as week 4 or week 12 minus baseline so that negative values indicate a reduction (improvement) of hot flash frequency.
Time Frame
Baseline, 4 weeks, and 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: To have participated in this study, a subject MUST: be a postmenopausal woman between 40 and 65 years of age, inclusive be seeking relief or treatment for moderate to severe VMS be willing to discontinue and abstain from the following: vaginal hormonal products; transdermal or oral estrogen or estrogen/progestin combination; progestin implants; injectable estrogen; topical progesterone cream, selective estrogen receptor modulators and intrauterine devices (IUDs) have no clinically significant abnormalities on pelvic exam except for vulvovaginal atrophy (VVA) have a normal or clinically insignificant transvaginal ultrasound (TVU) with an endometrial thickness <4 mm at screening have a normal endometrial biopsy subsequent to the TVU without clinically relevant results have a normal screening Papanicolaou (Pap) smear have a mammogram within 9 months prior to randomization. Subjects must have had a Breast Imaging Reporting and Data System (BI-RADS) mammography result of 1 or 2 to enroll. Exclusion Criteria: Subjects with any of the following characteristics were not be eligible to participate in the study: have a history of invasive breast cancer or ductal carcinoma in situ, melanoma or any gynecologic cancer. using any of the following: oral estrogen-, progestin-, androgen-, or selective estrogen receptor modulator (SERM) containing drug products within 8 weeks before screening (visit 1) transdermal hormone products within 4 weeks before screening (visit 1) vaginal hormone products (rings, creams, gels) within 4 weeks before screening (visit 1) progestin implants/injectables, IUDs or estrogen pellets/injectables within 6 months before screening (visit 1) anabolic steroids have been treated with a gonadotropin-releasing hormone (GnRH) agonist within the last year have been treated with anti-estrogens or aromatase inhibitors within 2 months prior to study entry have been concurrently treated and will abstain from gabapentin and paroxetine or serotonin and norepinephrine reuptake inhibitors (SNRIs) for VMS or other indications for 3 months during the trial and have not taken within 4 weeks prior to screening have unexplained vaginal bleeding within the 3 months prior to study entry have an endometrial biopsy at baseline with a diagnosis by a gynecologic pathologist of proliferative, hyperplasia, polyp or cancer have unresolved cervical cytological smear report of atypical glandular or squamous cells of undetermined significance. Cervical cytologic smear report of ASCUS, low grade squamous intraepithelial lesion or greater, or any reported dysplasia have unresolved findings suspicious for malignancy on the breast examination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Operations
Organizational Affiliation
Radius Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Women's Health Care Specialists P.C. - Beyer Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Study to Evaluate the Safety and Efficacy of RAD1901 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms

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