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Trial record 3 of 4 for:    rad1901

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02653417
First Posted: January 12, 2016
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Radius Health, Inc.
  Purpose
The purpose of this study is to determine the clinical safety of and whether RAD1901 reduces the frequency and severity of VMS in postmenopausal women regardless of uterine status.

Condition Intervention Phase
Hot Flashes Drug: RAD1901 Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Radius Health, Inc.:

Primary Outcome Measures:
  • The objectives of this study are to determine the safety and efficacy of RAD1901 in postmenopausal women with moderate to severe VMS as assessed by a reduction from baseline in the frequency and severity of hot flashes [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:
  • Change from baseline in the severity of hot flashes at 4 and 12 weeks [ Time Frame: 4 and 12 weeks ]
  • Change from baseline in the frequency of moderate to severe hot flashes at 4 weeks [ Time Frame: 4 weeks ]
  • Change from baseline in the frequency of mild, moderate, and severe hot flashes at 4 and 12 weeks by eDiary [ Time Frame: 4 and 12 weeks ]

Estimated Enrollment: 300
Study Start Date: December 2015
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regimen 1
RAD1901 5 mg
Drug: RAD1901
RAD1901
Experimental: Regimen 2
RAD1901 10 mg
Drug: RAD1901
RAD1901
Experimental: Regimen 3
RAD1901 20 mg
Drug: RAD1901
RAD1901
Placebo Comparator: Regimen 4
Placebo
Other: Placebo
Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To participate 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 [e.g., ospemifene, raloxifene, tamoxifen, Duavee® (conjugated estrogens and bazedoxifene) and intrauterine devices (IUDs)]
  4. have a normal or clinically insignificant transvaginal ultrasound (TVU)
  5. have a normal endometrial biopsy subsequent to the TVU without clinically relevant results
  6. have a normal screening Papanicolaou (Pap) smear
  7. have a mammogram within 9 months prior to randomization. Subjects must have 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 will 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 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 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 an endometrial biopsy at baseline with a diagnosis by a gynecologic pathologist of proliferative, hyperplasia, polyp or cancer
  7. unresolved findings suspicious for malignancy on the breast examination
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653417


Locations
United States, Michigan
Women's Health Care Specialists P.C. - Beyer Research
Kalamazoo, Michigan, United States, 49009
Sponsors and Collaborators
Radius Health, Inc.
  More Information

Responsible Party: Radius Health, Inc.
ClinicalTrials.gov Identifier: NCT02653417     History of Changes
Other Study ID Numbers: VMRAD1901-203
First Submitted: January 8, 2016
First Posted: January 12, 2016
Last Update Posted: November 18, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms