POETRY: Study of Estrogen Replacement Therapy in Postmenopausal Women With Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

A Multi-Center, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study for the Safety, Tolerability and Efficacy of Estrogen Replacement Therapy (Conjugated Equine Estrogens 0.625 mg Daily) in Post Menopausal Women With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234676
• Other study ID #: POETRY06032003
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2005
• Last updated: December 24, 2007
• Start date: October 2003
• Est. completion date: March 2006

Study information

• Verified date: December 2007
• Source: The Parkinson Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary objectives of the POETRY study are to assess the safety and tolerability of estrogen replacement therapy (ERT) in postmenopausal women with Parkinson's disease (PD) and to assess recruitment for a study of ERT in postmenopausal women with PD.

Description:

POETRY is an 8-week study of 30 post-menopausal women with Parkinson's disease (PD) who will be enrolled at six clinical sites in the United States. The study is designed to measure the safety and tolerability of estrogen replacement therapy (ERT). The study will also measure how ERT affects thinking and behavior, movement and activities of daily living, as well as motor fluctuations and dyskinesias. Although we know there are gender differences in PD, no studies have assessed their impact on symptom management. Women with PD usually require less levodopa, are more likely to experience drug-related dyskinesia, and commonly report changes of their symptoms with menstruation, menopause and use of hormones, implying that hormonal changes may impact PD symptoms. All perimenopausal women face the decision whether or not to use estrogen replacement therapy (ERT) and for women with PD, information about estrogen's effects in PD may facilitate decision-making.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 75 Years

Eligibility

Inclusion Criteria:

• Post-menopausal women with Parkinson's disease who experience levodopa-related motor fluctuations averaging at least 2 hours daily in the "off" state confirmed by home diaries

• Must be on a stable dose of carbidopa/levodopa, immediate or controlled release therapy, antidepressants, or anxiolytics (for the last 30 days)

Exclusion Criteria:

• Insulin dependent diabetes

• Thyroid disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Premarin ®
Premarin ® 0.625 mg per day orally

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Maryland	Baltimore	Maryland
United States	Duke University Medical Center	Durham	North Carolina
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	University of Rochester	Rochester	New York
United States	The Parkinson's Institute	Sunnyvale	California

Sponsors (3)

Lead Sponsor	Collaborator
The Parkinson Study Group	Joseph and Rosalyn Newman Foundation, Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Adverse event frequency, vital signs (change from Baseline to Month 2)		60 days	Yes
Primary	Tolerability - Proportion of participants who complete the trial		60 days	Yes
Secondary	Motor		60 days	No
Secondary	Cognition		60 days	No
Secondary	Behavior		60 days	No
Secondary	Serum estradiol levels - change from Baseline to Month 2		60 days	No

External Links

•   Parkinson Study Group