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

NCT02653417 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: VMRAD1901-203
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Vasomotor Symptoms; Hot Flashes

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 weeks

Secondary Outcomes (3)

• Change From Baseline to Week 4 in the Frequency of Moderate to Severe Hot Flashes

  Baseline and 4 weeks

• Change From Baseline to Week 4 and Week 12 in the Severity of Hot Flashes

  Baseline, 4 weeks, and 12 weeks

• Change From Baseline to Week 4 and Week 12 in the Frequency of All Hot Flashes

  Baseline, 4 weeks, and 12 weeks

Study Arms (4)

Regimen 1

EXPERIMENTAL

RAD1901 5 mg/day

Drug: RAD1901

Regimen 2

EXPERIMENTAL

RAD1901 10 mg/day

Drug: RAD1901

Regimen 3

EXPERIMENTAL

RAD1901 20 mg/day

Drug: RAD1901

Regimen 4

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

RAD1901 DRUG

RAD1901

Also known as: Elacestrant

Regimen 1; Regimen 2; Regimen 3

Placebo OTHER

Placebo

Regimen 4

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Radius Pharmaceuticals, Inc.: lead

Study Sites (1)

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

Kalamazoo, Michigan, 49009, United States

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

RAD1901; elacestrant

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Operations
• Organization: Radius Pharmaceuticals, Inc.

clinopsinfo@radiuspharm.com

617-551-4000

Study Officials

• Clinical Operations

  Radius Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 12, 2016
• Study Start: December 1, 2015
• Primary Completion: December 12, 2016
• Study Completion: May 1, 2018
• Last Updated: March 13, 2019
• Results First Posted: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)