Clinical trial NCT00234676: POETRY: Study of Estrogen Replacement Therapy in Postmenopausal Women With Parkinson's Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson disease
women
postmenopause
estrogen replacement therapy
clinical trials
Lead sponsor: The Parkinson Study Group
Sponsor class: NETWORK
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
name: Joseph and Rosalyn Newman Foundation
First posted: 2005-10-07
Enrollment: 23
Sex: FEMALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Safety - Adverse event frequency, vital signs (change from Baseline to Month 2)
timeFrame: 60 days
measure: Tolerability - Proportion of participants who complete the trial
timeFrame: 60 days
Secondary outcomes:
measure: Motor
timeFrame: 60 days
measure: Cognition
timeFrame: 60 days
measure: Behavior
timeFrame: 60 days
measure: Serum estradiol levels - change from Baseline to Month 2
timeFrame: 60 days
Other outcomes:
Locations:
city: Sunnyvale
country: United States
facility: The Parkinson's Institute
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: University of Maryland
name: Lisa M Shulman, MD
role: PRINCIPAL_INVESTIGATOR
References: