Estrogen Treatment in Acromegalic Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Acromegaly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Alesse

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Omar Serri, MD

Role: PRINCIPAL_INVESTIGATOR

CHUM- Endocrinology

Locations

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CHUM - Notre-Dame Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Omar SERRI, MD

Role: CONTACT

Phone: 514-890-8000

Email: [email protected]

References

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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.

Reference Type DERIVED

PMID: 32524605 (View on PubMed)

Other Identifiers

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HND01

Identifier Type: -

Identifier Source: org_study_id