Hot FlashesPhase 2NCT00875420

A Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women

A Phase 2 study testing RAD1901 in people with Hot Flashes, run by Radius Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether RAD1901 is effective in decreasing hot flashes in postmenopausal women. Read more about this study

Who is it for?: Ages 40 to 75 years, women only
Conditions the study is for: Hot Flashes
What is being tested?: RAD1901
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteUnited States
Study dates: Mar 2009to Apr 2010
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 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Have documented evidence of a minimum of 7 moderate to severe hot flashes per day, or 50 per week.
Be in good general health as determined by medical history, physical examination, and inclusion procedures and is without evidence of any clinically significant abnormalities.
Have a normal pelvic assessment with no clinically significant signs on examination and pelvic ultrasound.
Have a normal mammogram at the time of study screening.

Who cannot join

A history of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic, immunologic or metabolic diseases to a degree that would compromise patient safety or interfere with the interpretation of study data. A history of active presence of thrombophlebitis, thrombosis, thromboembolic disorders.
A history of active presence of stroke, transient ischemic attack (TIA), heart attack or ischemic heart disease.
Unexplained vaginal bleeding within the 3 months prior to study entry.

Trial locations and contacts

1 site in 1 country.

United States1 site

Radius Health, Inc.
Cambridge, Massachusetts, 02139

Other trials in United States

About this study

Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 2, Multi-Center, Dose-Finding Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women

The purpose of this study is to determine whether RAD1901 is effective in decreasing hot flashes in postmenopausal women.

Conditions: Hot Flashes
Being tested: RAD1901, Placebo
Keywords: hot flashes, hot flushes, vasomotor symptoms, postmenopausal
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
10 mg Oral once a day for 28 days.
RAD1901Drug
25 mg Oral once a day for 28 days
RAD1901Drug
50 mg Oral once a day for 28 days.
RAD1901Drug
100 mg Oral once a day for 28 days
PlaceboDrug
Placebo Oral once a day for 28 days

Study groups in NCT00875420
Study group	Role	What they receive
RAD1901 10 mg	Experimental	Oral once a day for 28 days Receives: Drug: RAD1901
RAD1901 25 mg	Experimental	Oral once a day for 28 days Receives: Drug: RAD1901
RAD1901 50 mg	Experimental	Oral once a day for 28 days Receives: Drug: RAD1901
RAD1901 100 mg	Experimental	Oral once a day for 28 days Receives: Drug: RAD1901
Placebo	Placebo comparator	Oral once a day for 28 days Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in Frequency of Hot Flashes Over Time
Percent change of moderate and severe hot flash frequency at 4 weeks compared to baseline using weekly Subject diary data, in the intent-to-treat population.
Measured: Week 4 minus baseline week
Percent Change in Composite Score Over Time
Percent change in composite score (frequency x severity) of hot flashes (Mild=1, Moderate=2, Severe=3) at 4 weeks compared to baseline, in the intent-to-treat population.
Measured: Week 4 minus baseline week

Secondary outcomes (2)

Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time.
Percent change in FSH at Day 29 compared to baseline, in the intent-to-treat population.
Measured: Day 29 minus baseline
Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time.
Percent change in LH levels at Day 29 compared to baseline, in the intent-to-treat population.
Measured: Day 29 minus baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Apr 2010

First posted3 Apr 2009 (estimated)
Study startMar 2009
Primary completionJan 2010
Study completionApr 2010

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hot FlashesStudies 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00875420
Sponsor's protocol ID: RAD1901-002
Status last verified: Aug 2018
First submitted: 6 Mar 2009
Last updated: 26 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hattersley G, Harris AG, Simon JA, Constantine GD. Clinical investigation of RAD1901, a novel estrogen receptor ligand, for the treatment of postmenopausal vasomotor symptoms: a phase 2 randomized, placebo-controlled, double-blind, dose-ranging, proof-of-concept trial. Menopause. 2017 Jan;24(1):92-99. doi: 10.1097/GME.0000000000000726.
PubMed 27575546

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hot Flashes trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 2, Multi-Center, Dose-Finding Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women
ClinicalTrials.gov ID: NCT00875420
Acronym / sponsor ID: RAD1901-002
Conditions: Hot Flashes
Keywords: hot flashes, hot flushes, vasomotor symptoms, postmenopausal
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Radius Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Jan 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 3 Apr 2009 (estimated)
Results: Posted 26 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine whether RAD1901 is effective in decreasing hot flashes in postmenopausal women.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
RAD1901 10 mg	Experimental	Drug: RAD1901Oral once a day for 28 days
RAD1901 25 mg	Experimental	Drug: RAD1901Oral once a day for 28 days
RAD1901 50 mg	Experimental	Drug: RAD1901Oral once a day for 28 days
RAD1901 100 mg	Experimental	Drug: RAD1901Oral once a day for 28 days
Placebo	Placebo comparator	Drug: PlaceboOral once a day for 28 days

Who may qualify

Ages: 40 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Have documented evidence of a minimum of 7 moderate to severe hot flashes per day, or 50 per week.
Be in good general health as determined by medical history, physical examination, and inclusion procedures and is without evidence of any clinically significant abnormalities.
Have a normal pelvic assessment with no clinically significant signs on examination and pelvic ultrasound.
Have a normal mammogram at the time of study screening.

Key exclusion criteria (3 listed)

A history of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic, immunologic or metabolic diseases to a degree that would compromise patient safety or interfere with the interpretation of study data. A history of active presence of thrombophlebitis, thrombosis, thromboembolic disorders.
A history of active presence of stroke, transient ischemic attack (TIA), heart attack or ischemic heart disease.
Unexplained vaginal bleeding within the 3 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
RAD190110 mg Oral once a day for 28 days.	Drug	RAD1901 10 mg
RAD190125 mg Oral once a day for 28 days	Drug	RAD1901 25 mg
RAD190150 mg Oral once a day for 28 days.	Drug	RAD1901 50 mg
RAD1901100 mg Oral once a day for 28 days	Drug	RAD1901 100 mg
PlaceboPlacebo Oral once a day for 28 days	Drug	Placebo

Primary outcome

Percent Change in Frequency of Hot Flashes Over Time
Time frame: Week 4 minus baseline week
Percent change of moderate and severe hot flash frequency at 4 weeks compared to baseline using weekly Subject diary data, in the intent-to-treat population.
Percent Change in Composite Score Over Time
Time frame: Week 4 minus baseline week
Percent change in composite score (frequency x severity) of hot flashes (Mild=1, Moderate=2, Severe=3) at 4 weeks compared to baseline, in the intent-to-treat population.

2 secondary outcomes

Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time.
Time frame: Day 29 minus baseline
Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time.
Time frame: Day 29 minus baseline

Results and safety

Results posted to the registry on 26 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RAD1901 10 mg	22	20
RAD1901 25 mg	20	18
RAD1901 50 mg	21	18
RAD1901 100 mg	18	16
Placebo	19	17

Primary outcome: Percent Change in Frequency of Hot Flashes Over Time

Time frame: Week 4 minus baseline week. Mean (Standard Deviation). Unit: Percent change from baseline

Measure	RAD1901 10 mg n = 22	RAD1901 25 mg n = 20	RAD1901 50 mg n = 21	RAD1901 100 mg n = 18	Placebo n = 19
Value	-77.2 (20.43)	-51.8 (45.02)	-53.8 (39.16)	-67.0 (33.85)	-54.1 (37.72)

Population analysed: The intent-to-treat population is defined as all patients who received one or more doses of study drug.

Primary outcome: Percent Change in Composite Score Over Time

Time frame: Week 4 minus baseline week. Mean (Standard Deviation). Unit: Percent change from baseline

Measure	RAD1901 10 mg n = 22	RAD1901 25 mg n = 20	RAD1901 50 mg n = 21	RAD1901 100 mg n = 18	Placebo n = 19
Value	-75.65 (18.655)	-55.48 (39.442)	-48.78 (39.806)	-66.21 (33.226)	-55.80 (35.523)

Population analysed: The intent-to-treat population is defined as all patients who received one or more doses of study drug.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for 2 months during this study; from start of treatment to the end-of-treatment visit (Day 29) and 30 days after end-of-treatment visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RAD1901 10 mg	0 of 22 (0%)	16 of 22 (72.7%)	Not reported
RAD1901 25 mg	0 of 20 (0%)	14 of 20 (70%)	Not reported
RAD1901 50 mg	0 of 21 (0%)	14 of 21 (66.7%)	Not reported
RAD1901 100 mg	0 of 18 (0%)	14 of 18 (77.8%)	Not reported
Placebo	0 of 19 (0%)	11 of 19 (57.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27575546Hattersley G, Harris AG, Simon JA, Constantine GD. Clinical investigation of RAD1901, a novel estrogen receptor ligand, for the treatment of postmenopausal vasomotor symptoms: a phase 2 randomized, placebo-controlled, double-blind, dose-ranging, proof-of-concept trial. Menopause. 2017 Jan;24(1):92-99. doi: 10.1097/GME.0000000000000726.

Related trials for Hot Flashes

RecruitingPhase 2/3
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RecruitingPhase 3
A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause
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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.

Medical Director study director

Radius Health, 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 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 26 Sep 2018. 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 26 Mar 2012). 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?

Percent Change in Frequency of Hot Flashes Over Time (time frame: Week 4 minus baseline week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00875420, which also lists 1 linked publication.

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 26 Sep 2018.