Condition category
Urological and Genital Diseases
Date applied
23/06/2010
Date assigned
08/07/2010
Last edited
08/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hung-Ming Wu

ORCID ID

Contact details

135 Nanxiao St.
Changhua City
Changhua
500
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KTCT-P2a

Study information

Scientific title

Treatment of hot flashes with low-dose risperidone: An uncontrolled pilot study

Acronym

Study hypothesis

By chance, risperidone was reported to have an effect on remission of hot flashes. We postulate that risperidone could sereve as a potential drug to treat hot flashes.

Ethics approval

The Research Ethics Committee of Kuang-Tein General Hospital approved on the 20th of March 2005 (ref: KTCTP2a)

Study design

Pilot prospective non-randomised uncontrolled trial

Primary study design

Interventional

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Hot flashes

Intervention

Patients complete hot flash diaries regarding the frequency and severity of hot flashes everyday in a one-week baseline period, in the 3-month risperidone treatment period, and during the first two weeks after total risperidone withdrawal.

Intervention type

Other

Phase

Phase I

Drug names

Primary outcome measures

The efficacy of risperidone for hot flashes is assessed by the average number of hot flashes per day, and the average daily hot-flash score (frequency × severity)

Secondary outcome measures

None

Overall trial start date

01/06/2005

Overall trial end date

31/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Menopausal (perimenopausal or postmenopausal) women with at least a moderate severity (i.e., ≥ 2 on a 0–4 scale) of hot flashes

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

6

Participant exclusion criteria

1. Menopausal women who take antipsychotic drug or/and antidepressants
2. Menopausal women who have breast cancer

Recruitment start date

01/06/2005

Recruitment end date

31/05/2006

Locations

Countries of recruitment

Taiwan

Trial participating centre

135 Nanxiao St.
Changhua
500
Taiwan

Sponsor information

Organisation

Kuang-Tien General Hospital (Taiwan)

Sponsor details

135 Nanxiao St.
Changhua City
Changhua
500
Taiwan

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Kuang-Tien General Hospital (Taiwan) - investigator led study

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes