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

Radius Health

Status and phase: Completed; Phase 2

Conditions: Hot Flashes

Treatments: Drug: RAD1901; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00875420

RAD1901-002

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. 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.
2. A history of active presence of stroke, transient ischemic attack (TIA), heart attack or ischemic heart disease.
3. Unexplained vaginal bleeding within the 3 months prior to study entry.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 5 patient groups, including a placebo group

RAD1901 10 mg

Experimental group

Description:

Oral once a day for 28 days

Treatment:

Drug: RAD1901

Drug: RAD1901

Drug: RAD1901

Drug: RAD1901

RAD1901 25 mg

Experimental group

Description:

Oral once a day for 28 days

Treatment:

Drug: RAD1901

Drug: RAD1901

Drug: RAD1901

Drug: RAD1901

RAD1901 50 mg

Experimental group

Description:

Oral once a day for 28 days

Treatment:

Drug: RAD1901

Drug: RAD1901

Drug: RAD1901

Drug: RAD1901

RAD1901 100 mg

Experimental group

Description:

Oral once a day for 28 days

Treatment:

Drug: RAD1901

Drug: RAD1901

Drug: RAD1901

Drug: RAD1901

Placebo

Placebo Comparator group

Description:

Oral once a day for 28 days

Treatment:

Drug: Placebo