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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Amgen

Current Primary Outcome: Ratio of week 4 to baseline frequency of moderate to severe daily HFs [ Time Frame: 4 weeks ]

The 4-week endpoint frequency is defined as the average hot flash frequency over 7 days between weeks 3 and 4


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Ratio of week 4 to baseline daily hot flash severity score [ Time Frame: 4 weeks ]
  • Number of treatment emergent adverse events per subject [ Time Frame: 16 weels ]
  • The maximum observed concentration after a single dose of AMG 334 [ Time Frame: 16 weeks ]
  • The number of subjects with anti-AMG 334 antibodies after a single dose of AMG 334 [ Time Frame: 16 weeks ]
  • The time to maximum concentration after a single dose of AMG 334 [ Time Frame: 16 weeks ]
  • The area under the serum-concentration curve after a single dose of AMG 334 [ Time Frame: 16 weeks ]


Original Secondary Outcome: Same as current

Information By: Amgen

Dates:
Date Received: May 13, 2013
Date Started: May 2013
Date Completion:
Last Updated: November 11, 2014
Last Verified: October 2014