Estrogen Treatment in Acromegalic Women | NCT00315107

Studies
Estrogen Treatment in Acromegalic Women

NCT00315107

Sponsor

Université de Montréal

Status

Unknown status

Last Update Posted

May 26, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Acromegaly

Interventions

Alesse

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

May 2006

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 2006

Primary Completion Date

Not provided

Completion Date

Aug 2007

First Submitted Date

Apr 13, 2006

First Submission Date that Met QC Criteria

Apr 13, 2006

First Posted Date

Apr 17, 2006Estimated

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 25, 2006

Last Update Posted Date

May 26, 2006Estimated

Name	Class
Novartis	INDUSTRY

Description Module

Brief Summary

Oral estrogens may be an effective adjuvant treatment for control of acromegaly in patients with resistance to somatostatin analogs.

Detailed Description

This will be a canadian multicenter study with a randomized, double-blind, placebo-controlled design, to assess the efficacy and safety of adjuvant alesse in female acromegalic patients with suboptimal response to sandostatin LAR treatment.

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

Name	Type	Description	Arm Group Labels	Other Names
Alesse	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women 18 years and older treated with somatostatin analogs
Active acromegaly

Exclusion Criteria:

Cardiovascular or cerebrovascular disease
Thrombophlebitis or thromboembolism
Breast cancer
Non-controlled arterial hypertension
Smoking
Pregnancy or lactation

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Omar SERRI, MD	Contact	514-890-8000	25607	omar.serri@umontreal.ca

Overall Officials

Name	Affiliation	Role
Omar Serri, MD	CHUM- Endocrinology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHUM - Notre-Dame Hospital	Recruiting	Montreal	Quebec	H2L 4M1	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32524605	Derived	Kestler E, Ambrosio G, Hemming K, Hughes JP, Matute J, Moreno M, Madriz S, Walker D. An integrated approach to improve maternal and perinatal outcomes in rural Guatemala: A stepped-wedge cluster randomized trial. Int J Gynaecol Obstet. 2020 Oct;151(1):109-116. doi: 10.1002/ijgo.13262. Epub 2020 Jul 27.

ID	Term
D001849	Bone Diseases, Endocrine
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006964	Hyperpituitarism

ID	Term
D004997	Ethinyl Estradiol
D009651	Norpregnatrienes
D009650	Norpregnanes
D009654	Norsteroids