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

Primary Purpose

Menstruation Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anastrozole
Sponsored by
Meditrina Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menstruation Disorders

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Jasper Research Clinic
  • University Women's Care

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Anastrozole - A

Anastrozole -B

Anastrozoe - C

Anastrozole - D

Anastrozole - E

Anastrozole - F

Arm Description

Treatment for 26 consecutive days

Treatment for 7 consecutive days early in menstrual cycle

Treatment for 7 consecutive days mid follicular phase

Treatment for 7 consecutive days - mid cycle

Treatment for 7 consecutive days - luteal

Treatment with placebo for 26 consecutive days

Outcomes

Primary Outcome Measures

Endometrial thickness as measured by transvaginal ultrasound, safety

Secondary Outcome Measures

Full Information

First Posted
April 27, 2007
Last Updated
June 2, 2009
Sponsor
Meditrina Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00467493
Brief Title
Partial Double-Blind, Placebo-Controlled Study to Assess the Effect of Anastrozole on the Endometrium in Healthy Volunteers
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Meditrina Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstruation Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anastrozole - A
Arm Type
Experimental
Arm Description
Treatment for 26 consecutive days
Arm Title
Anastrozole -B
Arm Type
Experimental
Arm Description
Treatment for 7 consecutive days early in menstrual cycle
Arm Title
Anastrozoe - C
Arm Type
Experimental
Arm Description
Treatment for 7 consecutive days mid follicular phase
Arm Title
Anastrozole - D
Arm Type
Experimental
Arm Description
Treatment for 7 consecutive days - mid cycle
Arm Title
Anastrozole - E
Arm Type
Experimental
Arm Description
Treatment for 7 consecutive days - luteal
Arm Title
Anastrozole - F
Arm Type
Placebo Comparator
Arm Description
Treatment with placebo for 26 consecutive days
Intervention Type
Drug
Intervention Name(s)
Anastrozole
Primary Outcome Measure Information:
Title
Endometrial thickness as measured by transvaginal ultrasound, safety
Time Frame
Over one menstrual cycle

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Jasper Research Clinic
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
University Women's Care
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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