Partial Double-Blind, Placebo-Controlled Study to Assess the Effect of Anastrozole on the Endometrium in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Meditrina Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00467493
First received: April 27, 2007
Last updated: June 2, 2009
Last verified: June 2009
  Purpose

Aromatase inhibitors have been approved for use in postmenopausal women to treat and prevent breast cancer. They act by blocking the action of the enzyme, aromatase, that is necessary for the production of estradiol. This class of drugs, aromatase inhibitors, are very effective in reducing estradiol levels in postmenopausal women and in treating estrogen receptor positive breast cancers. This study is examining the effect of a specific inhibitor, anastrozole, on endometrial thickness in premenopausal women. The endometrium is sensitive to estradiol and also has local aromatase which, if inhibited, may result in reduced endometrial thickness. The main hypothesis is that anastrozole can be administered at any time during the menstrual cycle and reduce endometrial thickness compared to placebo.


Condition Intervention Phase
Menstruation Disorders
Drug: Anastrozole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Partial Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Anastrozole, an Aromatase Inhibitor, on Endometrial Thickness in Healthy Premenopausal Women When Dosed at Various Times During the Menstrual Cycle (Protocol M-001)

Resource links provided by NLM:


Further study details as provided by Meditrina Pharmaceuticals:

Primary Outcome Measures:
  • Endometrial thickness as measured by transvaginal ultrasound, safety [ Time Frame: Over one menstrual cycle ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: March 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anastrozole - A
Treatment for 26 consecutive days
Drug: Anastrozole
Experimental: Anastrozole -B
Treatment for 7 consecutive days early in menstrual cycle
Drug: Anastrozole
Experimental: Anastrozoe - C
Treatment for 7 consecutive days mid follicular phase
Drug: Anastrozole
Experimental: Anastrozole - D
Treatment for 7 consecutive days - mid cycle
Drug: Anastrozole
Experimental: Anastrozole - E
Treatment for 7 consecutive days - luteal
Drug: Anastrozole
Placebo Comparator: Anastrozole - F
Treatment with placebo for 26 consecutive days
Drug: Anastrozole

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between the ages of 25 and 45 and pre-menopausal;
  • Non-lactating and not pregnant
  • able to follow the schedule of procedures
  • able to freely provide informed consent
  • have clinically acceptable physical examination and safety laboratory studies

Exclusion Criteria:

  • current use of any form of systemic contraceptive
  • have self-reported irregular menstrual cycles
  • intercurrent illness(es) detected on the screening physical
  • unwilling or unable to use barrier methods of contraception
  • have evidence of endometrial polyps or myomata on TVU/SIS that would interfere with endometrial thickness measurement
  • detection of ovarian cyst(s) during adnexal examination on screening TVU/SIS measuring greater than 5 cm
  • have history of, or current cancer, on any form exclusive of basal cell carcinoma
  • BMI >= 35
  • history of alcohol or drug abuse in the past 5 years
  • unwilling or unable to undergo study procedures within the necessary time frames
  • history or current liver abnormalities as defined by ALT or AST > 2X ULN
  • treated or untreated diabetes defined as fasting blood sugar >= 126 mg/dL
  • untreated hypertension
  • impaired renal function by estimated creatinine clearance < 80mL/min
  • have estradiol levels < 20 pg/ml and FSH levels > 40 mIU/mL or
  • have a history of adverse reaction any aromatase inhibitor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467493

Locations
United States, Michigan
Jasper Research Clinic
Kalamazoo, Michigan, United States, 49007
University Women's Care
Southfield, Michigan, United States, 48034
Sponsors and Collaborators
Meditrina Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00467493     History of Changes
Other Study ID Numbers: M-001
Study First Received: April 27, 2007
Last Updated: June 2, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Menstruation Disturbances
Pathologic Processes
Anastrozole
Aromatase Inhibitors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014