The Effects of Isoflavone and Estrogen in Sex Response in... | NCT00905723

Studies
The Effects of Isoflavone and Estrogen in Sex Response in Climacteric Women

NCT00905723

Sponsor

Federal University of São Paulo

Status

Unknown status

Last Update Posted

May 20, 2009Estimated

Enrollment

60Estimated

Phase

Phase 3

Conditions

Postmenopausal Symptoms

Interventions

estradiol
isoflavone
Placebo

Countries

Brazil

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

May 2010Estimated

Completion Date

Not provided

First Submitted Date

May 19, 2009

First Submission Date that Met QC Criteria

May 19, 2009

First Posted Date

May 20, 2009Estimated

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

May 19, 2009

Last Update Posted Date

May 20, 2009Estimated

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

Climacterium is marked by hypoestrogenism and it is associated to drastic vasomotors symptoms, genital atrophy and humor alteration. Additionally, these symptoms impair sexual life and life quality. These effects can be counteracted by administration of estrogen therapy. However, estrogen therapy has side effects and isoflavone has been proposed as an estrogen substitute in reposition therapy. The aim of the randomized controlled trial is to evaluate the effects of isoflavone in the sex life assessed by a modified McCoy's sexual questionnaire.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Estrogen	Experimental	Women randomized to this group will receive daily pills containing 1 mg of estradiol	Drug: estradiol
Isoflavone	Experimental	Women randomized to this group will receive daily pills of 150 mg isoflavone	Drug: isoflavone
Placebo	Placebo Comparator	Women randomized to this group will be administered daily placebo pills	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
estradiol	Drug	1 mg daily for 6 months	Estrogen
isoflavone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
McCoy's sexual questionnaire		at recruitment and six months later

Secondary Outcomes

Measure	Description	Time Frame
Kupperman's index		at recruitment and six months later

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women aged 45-65 years old
presenting climacteric symptoms
sexual complaints

Exclusion Criteria:

hormonal therapy
counter indication to hormonal therapy
uncontrolled comorbidities

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Teresa R Embiruçu, M.D.	Contact	5511-75413521		embirucu2@yahoo.com.br
Regiane HB Rabelo, M.D.	Contact	5511-72307128		gianehelena@ig.com.br

Overall Officials

Name	Affiliation	Role
Mauro A Aidar, M.D., PhD	Universidade Federal de São Paulo	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ambulatório de Ginecologia Endócrina	Recruiting	São Paulo	São Paulo	04039-060	Brazil

Label	URL
Universidade Federal de São Paulo's web page	View source

Type	Date	Date Unknown
Release	Apr 11, 2016
Reset	May 16, 2016
Release	May 23, 2016
Reset	Jun 29, 2016

Submission Tracking

Estimated Results First Submitted Date

Apr 11, 2016

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 11, 2016			May 16, 2016
May 23, 2016

Intervention Browse Module

MeSH Terms

ID	Term
D004958	Estradiol
D007529	Isoflavones

Ancestor Terms

ID	Term
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided