Conditions: Orthostatic Intolerance
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 109
Healthy volunteers: yes

Brief summary:
This study is designed to determine the causes of "orthostatic intolerance" which occurs more commonly in women than in men. Orthostatic tolerance is the ability to remain standing up right for long periods of time, or to avoid dizziness when moving to standing from a seated or lying position.

Detailed description:
In this study we are interested in determining the impact of female reproductive hormones (estrogen and progesterone) on orthostatic tolerance (described above) so we administer these hormones to participants. We also test participants' orthostatic tolerance in our laboratory and use this information to place subjects into groups.

Arms:
arm 1: Subjects were given 250 μg in 0.5ml normal saline for 16 days. (Organon, Roseland, NJ, USA) arm 2: The same women added 17β-Oestradiol, E2; 0.2 mg day-1 patch (Vivelle; CIBA Pharmaceuticals, Summit, NJ) for days 4-16. arm 3: The same women added progesterone (P4, 200 mg day-1 Prometrium, oral, Solvay Pharmaceuticals, Marietta, GA, USA) on days 13-16.

Interventions: intervention 1: Ganirelix acetate intervention 2: 17β-Oestradiol intervention 3: Progesterone
Intervention descriptions: intervention 1: Ganirelix acetate: .25 ml/day by subcutaneous injection intervention 2: 17 beta estradiol: 0.2 mg/day (patches) intervention 3: progesterone, 200 mg day-1 oral

Protocol document: