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

Meditrina Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Menstruation Disorders

Treatments: Drug: Anastrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00467493

M-001

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 6 patient groups, including a placebo group

Anastrozole - A

Experimental group

Description:

Treatment for 26 consecutive days

Treatment:

Drug: Anastrozole

Anastrozole -B

Experimental group

Description:

Treatment for 7 consecutive days early in menstrual cycle

Treatment:

Drug: Anastrozole

Anastrozoe - C

Experimental group

Description:

Treatment for 7 consecutive days mid follicular phase

Treatment:

Drug: Anastrozole

Anastrozole - D

Experimental group

Description:

Treatment for 7 consecutive days - mid cycle

Treatment:

Drug: Anastrozole

Anastrozole - E

Experimental group

Description:

Treatment for 7 consecutive days - luteal

Treatment:

Drug: Anastrozole

Anastrozole - F

Placebo Comparator group

Description:

Treatment with placebo for 26 consecutive days

Treatment:

Drug: Anastrozole