Trial intelligence / Profile preview

Effect of Age on Gonadotropin Responses to Gonadal Steroids

NCT00455741Phase 2

Key facts

Status: Completed
Start: Nov 2000
Primary completion: Feb 2007
Countries: 1
Sponsor: Massachusetts General Hospital
Modality: Small Molecules

Drugs: estradiolprogesterone
Conditions: postmenopause

Overview

Phase 2, open-label trial of estradiol and progesterone in postmenopause (2 arms), sponsored by Massachusetts General Hospital. Primary endpoints: Effect of Aging on Estrogen Negative Feedback on LH at 24 hours and Effect of Aging on Estrogen Positive Feedback on LH at 120 hours. Started Nov 2000; status: completed.

Design

2 arms

Study design: Non-randomizedOpen-label

Young postmenopausal women
Women aged 45-55 receiving estradiol and progesterone infusions.
Older postmenopausal women
Women aged 70-80 receiving estradiol and progesterone infusions.

Who it enrols

Postmenopausal women, either young (45-55) or old (70-80), with normal thyroid, prolactin, CBC, and kidney function, and no history of coronary artery disease, breast cancer, or blood clots.

Endpoints

Primary

Effect of Aging on Estrogen Negative Feedback on LH24 hours
Effect of Aging on Estrogen Positive Feedback on LH120 hours

Secondary

18 FDG Uptake at the Pituitary During Estrogen Infusion: LH Negative Feedback24 hours
18 FDG Uptake at the Hypothalamus During Estrogen Infusion: LH Negative Feedback24 hours
18 FDG Uptake at the Pituitary During Estrogen Infusion: LH Positive Feedback72 hours
18 FDG Uptake at the Hypothalamus During Estrogen Infusion: LH Positive Feedback72 hours

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