Clinical Trial: Neuropeptide Treatment for Hot Flushes During the Menopause

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Neurokinin 3 Receptor Antagonism as a Novel Treatment for Menopausal Hot Flushes

Brief Summary: Placebo-controlled, double-blinded, cross-over clinical trial of a new investigational product

Detailed Summary:

Double-blinded, placebo-controlled, 2-way crossover study in 30 menopausal women with untreated hot flushes treated with a neurokinin 3 receptor (NK3R) antagonist

Aims:

To investigate whether an NK3R antagonist can reduce menopausal flushing

Treatment:

4 weeks administration of active drug and placebo in random order


Sponsor: Imperial College London

Current Primary Outcome: Mean hot flush (HF) frequency [ Time Frame: 4 weeks ]

Mean HF frequency (HF/day) per participant during the 4th week of a 4-week treatment period with placebo or AZD4901


Original Primary Outcome: Mean hot flush frequency [ Time Frame: 4 weeks ]

Mean HF frequency (HF/day) per participant during the 4th week of a 4-week treatment period with placebo or AZD4901


Current Secondary Outcome:

  • Mean hot flush (HF) frequency [ Time Frame: 1 week ]
    average mean HF frequency (HF/day) during the 1st week of a 4-week treatment period (days 1-7) will be compared when the patients receive AZD4901 versus placebo and also compared to the average HF frequency data during the 2nd week of the baseline period
  • Mean hot flush frequency [ Time Frame: 5 weeks ]
    average mean HF frequency (HF/day) during the 2nd week of a 4-week treatment period (days 8-14) will be compared when the patients receive AZD4901 versus placebo and also compared to the average HF frequency data during the 2nd week of the baseline period
  • Mean hot flush frequency [ Time Frame: 6 weeks ]
    average mean HF frequency (HF/day) during the 3rd week of a 4-week treatment period (days 15-21) will be compared when the patients receive AZD4901 versus placebo and also compared to the average HF frequency data during the 2nd week of the baseline period
  • Hot flush severity [ Time Frame: 14 weeks ]
    HF severity (rated as 1-nil, 2-mild, 3-moderate, 4-severe, as per Joffe 2014) will be recorded twice daily (day/night as described above for HF frequency). The data will be analysed as detailed above for the HF frequency
  • Hot flush bother [ Time Frame: 14 weeks ]
    HF bother (rated as 1-none, 2-a little, 3-moderate, 4-a lot, as per Joffe 2014) will be recorded twice daily (day/night as described above for HF frequency). The data will be analysed as detailed above for the HF frequency.
  • Hot flush interference [ Time Frame: 14 weeks ]
    HF interference (Hot Flash Related Daily Interference Scale, as per Carpenter 2001) will be recorded daily at bedtime. The data will be analysed as detailed above for the HF frequency.
  • Gonadotrophins & Oestradiol. [ Time Frame: 14 weeks ]
    Blood will be taken at each weekly visit throughout entire study period to measure gonadotrophins & Oestradiol.
  • Skin conductance monitor data. [ Time Frame: 14 weeks ]
    This will be measured for 48 hours non-invasively using a monitor placed on the sternal skin surface following each weekly visit. Mean number of flushes detected during the 48 hours by the skin conductance monitoring will be compared each week when the patients receive AZD4901 versus placebo and also compared to the skin conductance monitor data during the 2nd week of the baseline period


Original Secondary Outcome:

  • Mean hot flush frequency [ Time Frame: 1 week ]
    average mean HF frequency (HF/day) during the 1st week of a 4-week treatment period (days 1-7) will be compared when the patients receive AZD4901 versus placebo and also compared to the average HF frequency data during the 2nd week of the baseline period
  • Mean hot flush frequency [ Time Frame: 5 weeks ]
    average mean HF frequency (HF/day) during the 2nd week of a 4-week treatment period (days 8-14) will be compared when the patients receive AZD4901 versus placebo and also compared to the average HF frequency data during the 2nd week of the baseline period
  • Mean hot flush frequency [ Time Frame: 6 weeks ]
    average mean HF frequency (HF/day) during the 3rd week of a 4-week treatment period (days 15-21) will be compared when the patients receive AZD4901 versus placebo and also compared to the average HF frequency data during the 2nd week of the baseline period
  • Hot flush severity [ Time Frame: 14 weeks ]
    HF severity (rated as 1-nil, 2-mild, 3-moderate, 4-severe, as per Joffe 2014) will be recorded twice daily (day/night as described above for HF frequency). The data will be analysed as detailed above for the HF frequency
  • Hot flush bother [ Time Frame: 14 weeks ]
    HF bother (rated as 1-none, 2-a little, 3-moderate, 4-a lot, as per Joffe 2014) will be recorded twice daily (day/night as described above for HF frequency). The data will be analysed as detailed above for the HF frequency.
  • Hot flush intereference [ Time Frame: 14 weeks ]
    HF interference (Hot Flash Related Daily Interference Scale, as per Carpenter 2001) will be recorded daily at bedtime. The data will be analysed as detailed above for the HF frequency.
  • Gonadotrophins & Oestradiol. [ Time Frame: 14 weeks ]
    Blood will be taken at each weekly visit throughout entire study period to measure gonadotrophins & Oestradiol.
  • Skin conductance monitor data. [ Time Frame: 14 weeks ]
    This will be measured for 48 hours non-invasively using a monitor placed on the sternal skin surface following each weekly visit. Mean number of flushes detected during the 48 hours by the skin conductance monitoring will be compared each week when the patients receive AZD4901 versus placebo and also compared to the skin conductance monitor data during the 2nd week of the baseline period


Information By: Imperial College London

Dates:
Date Received: January 26, 2016
Date Started: February 2016
Date Completion: September 2017
Last Updated: March 27, 2017
Last Verified: March 2017