A Clinical Study to Evaluate the Effects of Estrogen in Healthy Postmenopausal Women

This study has been completed.

Study NCT00820664 Information provided by Merck

First Received on January 8, 2009. Last Updated on May 10, 2010 History of Changes

Results First Received: April 13, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Diagnostic
Condition:	Postmenopausal Symptoms
Interventions:	Drug: Comparator: Estrace 0.5 mg Drug: Comparator: Estrace 2 mg Drug: Comparator: Placebo

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited through advertisement and review of patient databases at Comprehensive Phase I, USA, between December 2008 and April 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Major entry criteria - healthy postmenopausal women within 10 years of attaining menopause as determined by follicle-stimulating hormone (FSH) and estradiol levels within range of postmenopause, and other criteria. Normal transvaginal ultrasound at screening with endometrial thickening at < 5.0 mm.

Reporting Groups

	Description
17β-estradiol 2.0 Milligrams	Estrace 2.0 mg tablet
17β-estradiol 0.5 Milligrams	Estrace 0.5 mg tablet
Placebo	No text entered.

Participant Flow: Overall Study

	17β-estradiol 2.0 Milligrams	17β-estradiol 0.5 Milligrams	Placebo
STARTED	9	11	9
COMPLETED	9	11	9
NOT COMPLETED	0	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
17β-estradiol 2.0 Milligrams	Estrace 2.0 mg tablet
17β-estradiol 0.5 Milligrams	Estrace 0.5 mg tablet
Placebo	No text entered.

Baseline Measures

	17β-estradiol 2.0 Milligrams	17β-estradiol 0.5 Milligrams	Placebo	Total
Number of Participants [units: participants]	9	11	9	29
Age [units: years] Mean ± Standard Deviation	54.11 ± 3.76	53.91 ± 5.65	55.33 ± 3.04	54.41 ± 4.30
Gender [units: participants]
Female	9	11	9	29
Male	0	0	0	0
Race/Ethnicity, Customized [units: participants]
Black	1	0	0	1
White	8	11	9	28
Body Mass Index (BMI) [units: kg/m^2] Mean ± Standard Deviation	27.87 ± 3.95	28.69 ± 2.74	27.43 ± 1.98	28.05 ± 2.92

Outcome Measures

1. Primary:

Immunohistochemistry (IHC) Proliferative Effects Measurement [ Time Frame: 4 weeks ]

Show Outcome Measure 1

2. Secondary:

Mean Gene Expression Intensity After 4 Weeks of Either 0.5 or 2 mg Estrace Compared to Placebo. [ Time Frame: 4 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The registered secondary outcome: "Mean gene expression intensity after 4 weeks of either 0.5 or 2 mg Estrace compared to placebo" results are not available because of inadequate quantity and quality of tissue samples that were obtained.

Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00820664 History of Changes
Other Study ID Numbers:	2009_505, 122
Study First Received:	January 8, 2009
Results First Received:	April 13, 2010
Last Updated:	May 10, 2010
Health Authority:	United States: Institutional Review Board