NCT00234676

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: The Parkinson Study Group · Network
• Sex: Female
• Age: 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Premarin ®	Premarin ® 0.625 mg per day orally

Timeline

• Start date: 2003-10-01
• Primary completion: 2006-03-01
• Completion: 2006-03-01
• First posted: 2005-10-07
• Last updated: 2008-01-08

Locations

6 sites across 1 country: United States