Efficacy of Therapy With the Spironolactone Pills Compare... | NCT00175617

Studies
Efficacy of Therapy With the Spironolactone Pills Compared to Minoxidil Lotion in Female Pattern Hair Loss

NCT00175617

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Mar 3, 2017Actual

Enrollment

40Estimated

Phase

Phase 2

Conditions

Female Pattern Hair Loss

Interventions

Spironolactone
Minoxidil

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Mar 9, 2009Actual

Completion Date

Mar 9, 2009Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2017

Last Update Posted Date

Mar 3, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spironolactone	Drug	This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.
Minoxidil	Drug	This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hair density		after 3, 6 and 9 months

Secondary Outcomes

Measure	Description	Time Frame
percentage of subjects who experience side effects
subject assessment of treatment effect

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must be premenopausal women older than 18 with female pattern hair loss.

Exclusion Criteria:

Androgen excess
Other scalp or hair disorders
Contraindications to spironolactone treatment, especially pregnancy, electrolyte imbalances, history of breast cancer, or intake of interfering drugs
Contraindications to minoxidil treatment, especially patients who are allergic to this treatment or have a history of low blood pressure or irregular heart beats

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jerry Shapiro, MD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UBC Division of Dermatology, Hair Research and Treatment Centre		Vancouver	British Columbia	V6G 1Y6	Canada

Intervention Browse Module

MeSH Terms

ID	Term
D013148	Spironolactone
D008914	Minoxidil

Ancestor Terms

ID	Term
D007783	Lactones
D009930	Organic Chemicals
D011283	Pregnenes
D011278	Pregnanes
D013256

Browse Leaves

Not provided

Browse Branches

Not provided