Randomized, Parallel-group, Double-blind, Placebo-controlled, Study to AMG 334 in Women With Hot Flashes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01890109
First received: May 13, 2013
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

This is a randomized, stratified, double-blind, placebo-controlled, parallel-group study in female subjects with HFs associated with menopause. This study will evaluate the efficacy of AMG 334 as measured by reduction from baseline in the frequency and severity of daily HFs at weeks 2, 4, 8, 12, and 16 after a single dose of AMG 334.


Condition Intervention Phase
Vasomotor Symptoms; Hot Flashes
Drug: AMG 334
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Stratified, Parallel-group, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 334 in Women With Hot Flashes Associated With Menopause

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Ratio of week 4 to baseline frequency of moderate to severe daily HFs [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The 4-week endpoint frequency is defined as the average hot flash frequency over 7 days between weeks 3 and 4


Secondary Outcome Measures:
  • Ratio of week 4 to baseline daily hot flash severity score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of treatment emergent adverse events per subject [ Time Frame: 16 weels ] [ Designated as safety issue: Yes ]
  • The maximum observed concentration after a single dose of AMG 334 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • The number of subjects with anti-AMG 334 antibodies after a single dose of AMG 334 [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • The time to maximum concentration after a single dose of AMG 334 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • The area under the serum-concentration curve after a single dose of AMG 334 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: May 2013
Estimated Study Completion Date: October 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AMG 334 Treatment A
Single dose level administered via SC in female subjects with hot flashes associated with menopause.
Drug: AMG 334
Single dose level administered via SC in female subjects with hot flashes associated with menopause.
Placebo Comparator: AMG 334 Treatment B
Single dose level administered via SC in female subjects with hot flashes associated with menopause.
Drug: AMG 334
Single dose level administered via SC in female subjects with hot flashes associated with menopause

Detailed Description:

This is a randomized, stratified, double-blind, placebo-controlled, parallel-group study in female subjects with HFs associated with menopause. This study will evaluate the efficacy of AMG 334 as measured by reduction from baseline in the frequency and severity of daily HFs at weeks 2, 4, 8, 12, and 16 after a single dose of AMG 334.

Study Phase: 1b

Primary Objective:

To evaluate the frequency of moderate to severe daily HFs at week 4 after a single dose of AMG 334 in female subjects with HFs associated with menopause.

Secondary Objectives:

To evaluate changes in the severity of daily HFs at week 4 after a single dose of AMG 334 in female subjects with moderate to severe HFs associated with menopause.

To evaluate the safety, tolerability, and immunogenicity of AMG 334 in female subjects with HFs associated with menopause

To characterize the pharmacokinetic (PK) profile of AMG 334 after a single subcutaneous (SC) dose in female subjects with HFs associated with menopause

Hypotheses:

This study will test the hypothesis that the vasodilation associated with capsaicin-induced dermal blood flow (DBF) provides a good model for the vasodilation associated with HFs; therefore AMG 334 doses that cause DBF inhibition will be safe and well tolerated, and will be effective in the reduction of the frequency and/or severity of HFs.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female subjects with hot flashes associated with menopause between 45 and 65 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician.

Exclusion Criteria:

  • History or evidence of clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890109

Locations
United States, California
Research Site
San Diego, California, United States, 92108
United States, Florida
Research Site
Miami, Florida, United States, 33186
United States, North Carolina
Research Site
Winston Salem, North Carolina, United States, 27103
United States, Pennsylvania
Eugene Andruczyk
Philadelphia, Pennsylvania, United States, 19114
Research Site
Philadelphia, Pennsylvania, United States, 19114
United States, South Carolina
Research Site
Mt. Pleasant, South Carolina, United States, 29464
United States, Washington
Research Site
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01890109     History of Changes
Other Study ID Numbers: 20120180
Study First Received: May 13, 2013
Last Updated: October 1, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Amgen:
Vasomotor symptoms; Hot Flashes

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014