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
About this trial
This is an interventional treatment trial for Menstruation Disorders
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
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
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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