Black Cohosh for Host Flashes Due to Androgen Deprivation Therapy
Status:
Withdrawn
Trial end date:
2018-11-01
Target enrollment:
Participant gender:
Summary
This is a randomized, placebo-controlled crossover study. Participants will be actively
participating in the study for 6 months, and enrolled in the study for up to 1 year. During
the first phase of the study, the participants will be randomized into either the placebo
group or treatment group for 8 weeks following 1 week of baseline data collection (no
treatment). Following this first phase, a no-treatment washout period of at least 3 weeks
will be implemented for all participants. After the washout period, the randomized groups
will switch from treatment to placebo group, or placebo to treatment group for an additional
8 week period. Hot flash frequency and severity will be documented using a daily hot flash
diary and calculated using the Hot Flash Score questionnaire. The impact on quality of life
will be documented by weekly Hot Flash Related Daily Interference Scale (HFRDIS)
questionnaires.