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

Condition(s) targeted: Parkinson's Disease

Intervention: Premarin ® (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: The Parkinson Study Group

Official(s) and/or principal investigator(s):
Lisa M Shulman, MD, Principal Investigator, Affiliation: University of Maryland

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study

Primary outcome:

Safety - Adverse event frequency, vital signs (change from Baseline to Month 2)

Tolerability - Proportion of participants who complete the trial

Secondary outcome:

Motor

Cognition

Behavior

Serum estradiol levels - change from Baseline to Month 2

Detailed 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.

Minimum age: N/A. Maximum age: 75 Years. Gender(s): Female.

Criteria:

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

The Parkinson's Institute, Sunnyvale, California, United States

Emory University, Atlanta, Georgia, United States

Indiana University School of Medicine, Indianapolis, Indiana, United States

University of Maryland, Baltimore, Maryland, United States

University of Rochester, Rochester, New York, United States

Duke University Medical Center, Durham, North Carolina, United States

Parkinson Study Group

Starting date: October 2003
Ending date: March 2006
Last updated: December 24, 2007