Vasomotor SymptomsPhase 2NCT02653417
Study to Evaluate the Safety and Efficacy of RAD1901 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms
A Phase 2 study testing RAD1901 in people with Vasomotor Symptoms and Hot Flashes, run by Radius Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Vasomotor Symptoms, Hot Flashes
- What is being tested?
- RAD1901
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 1 May 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's Health Care Specialists P.C. - Beyer Research
Kalamazoo, Michigan, 49009
About this study
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
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.
Read the 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.
- Conditions
- Vasomotor Symptoms, Hot Flashes
- Being tested
- RAD1901, Placebo
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAD1901Drug
Also called Elacestrant
RAD1901
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Regimen 1 | Experimental | RAD1901 5 mg/day Receives: Drug: RAD1901 |
| Regimen 2 | Experimental | RAD1901 10 mg/day Receives: Drug: RAD1901 |
| Regimen 3 | Experimental | RAD1901 20 mg/day Receives: Drug: RAD1901 |
| Regimen 4 | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Secondary outcomes (3)
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.
Measured: Baseline and 4 weeks
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.
Measured: Baseline, 4 weeks, and 12 weeks
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.
Measured: Baseline, 4 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startDec 2015
- Primary completion12 Dec 2016
- Study completion1 May 2018
Why it stopped: Sponsor's Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vasomotor SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radius Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Operations, Study director, Radius Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653417
- Sponsor's protocol ID
- VMRAD1901-203
- Status last verified
- Mar 2019
- First submitted
- 8 Jan 2016
- Last updated
- 13 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02653417
- Acronym / sponsor ID
- VMRAD1901-203
- Conditions
- Vasomotor Symptoms, Hot Flashes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's Decision
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Radius Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- 12 Dec 2016 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Posted 13 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regimen 1 | Experimental | Drug: RAD1901RAD1901 5 mg/day |
| Regimen 2 | Experimental | Drug: RAD1901RAD1901 10 mg/day |
| Regimen 3 | Experimental | Drug: RAD1901RAD1901 20 mg/day |
| Regimen 4 | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAD1901Also: ElacestrantRAD1901 | Drug | Regimen 1, Regimen 2, Regimen 3 |
| PlaceboPlacebo | Other | Regimen 4 |
Primary outcome
Change From Baseline to Week 12 in the Frequency of Moderate to Severe Hot Flashes
Time frame: Baseline and 12 weeks
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.
3 secondary outcomes
Change From Baseline to Week 4 in the Frequency of Moderate to Severe Hot Flashes
Time frame: Baseline and 4 weeks
Change From Baseline to Week 4 and Week 12 in the Severity of Hot Flashes
Time frame: Baseline, 4 weeks, and 12 weeks
Change From Baseline to Week 4 and Week 12 in the Frequency of All Hot Flashes
Time frame: Baseline, 4 weeks, and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Vasomotor Symptoms
Not yet recruitingPhase 4
Migraine Menopause Study
Migraine, Menopausal
RecruitingPhase 2
FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
RecruitingPhase 3
A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause
Hot Flashes
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Operations study director
Radius Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RAD1901 in people with Vasomotor Symptoms and Hot Flashes, run by Radius Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 12 in the Frequency of Moderate to Severe Hot Flashes (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.