NCT00315107

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2006

Completed
14 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

May 26, 2006

Status Verified

May 1, 2006

First QC Date

April 13, 2006

Last Update Submit

May 25, 2006

Conditions

Acromegaly

Interventions

AlesseDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women 18 years and older treated with somatostatin analogs
  • Active acromegaly

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUM - Notre-Dame Hospital

Montreal, Quebec, H2L 4M1, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32524605DERIVED

MeSH Terms

Conditions

Acromegaly

Interventions

Ethinyl Estradiol-Norgestrel Combination

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Ethinyl EstradiolNorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsNorgestrelNorpregnenesEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Omar Serri, MD

    CHUM- Endocrinology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar SERRI, MD

CONTACT

514-890-8000omar.serri@umontreal.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 13, 2006

First Posted

April 17, 2006

Study Start

May 1, 2006

Study Completion

August 1, 2007

Last Updated

May 26, 2006

Record last verified: 2006-05

Locations

CA(1)