Sex Hormones and Orthostatic Tolerance

NCT01153581 | Completed Phase 2 Results

• 2 other identifiers: 0512000875a2R01HL071159-04
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthostatic Intolerance

Outcome Measures

Primary Outcomes (3)

• Orthostatic Tolerance

  We used a measure called cumulative stress index to determine orthostatic tolerance, which is the amount of time at a level of negative pressure each subject can maintain before feeling as if she is going to pass out. This is calculated by multiplying the pressure in mm Hg by the time in min.

  2 months

• Baroreceptor Function

  This is a measure of how the body responds to changes in pressure induced by changes in position such as sitting, lying standing. The pressure changes are induced by gravity. The measurement described below to assess baroreceptor function is units of change in forearm vascular resistance for a given change in lower body negative pressure. This allows us to determine how good the body is at sending signals to the periphery to respond to postural changes. Baroreflex sensitivity is defined as the change in interbeat interval (IBI) in milliseconds per unit change in BP. For example, when the BP rises by 10 mmHg and IBI increases by 100 ms, BRS would be 100/10 = 10 ms/mmHg.

  2 months

• Skin Microvascular Responses

  Changes in blood flow in the small vessel in the skin are measured in response to sequential heat and drug stimulation. It is measured in volts, and then corrected for a maximum level and expressed as "% max." This is measured with a Laser Doppler probes, which measures volts.

  2 months

Study Arms (3)

Ganirelix acetate

EXPERIMENTAL

Subjects were given 250 μg in 0.5ml normal saline for 16 days. (Organon, Roseland, NJ, USA)

Drug: Ganirelix acetate

17β-Oestradiol, E2

EXPERIMENTAL

The same women added 17β-Oestradiol, E2; 0.2 mg day-1 patch (Vivelle; CIBA Pharmaceuticals, Summit, NJ) for days 4-16.

Drug: 17β-Oestradiol

Progesterone

EXPERIMENTAL

The same women added progesterone (P4, 200 mg day-1 Prometrium, oral, Solvay Pharmaceuticals, Marietta, GA, USA) on days 13-16.

Drug: Progesterone

Interventions

Ganirelix acetate DRUG

Ganirelix acetate: .25 ml/day by subcutaneous injection

Also known as: Antagon

Ganirelix acetate

17β-Oestradiol DRUG

17 beta estradiol: 0.2 mg/day (patches)

Also known as: 17 beta estradiol, estradiol

17β-Oestradiol, E2

Progesterone DRUG

progesterone, 200 mg day-1 oral

Also known as: P4, Prometrium

Progesterone

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, English-speaking non-smoking women age 18- 34 with regular menses

You may not qualify if:

• Gynecologic:
• current or past estrogen-dependent neoplasia,
• unexplained vaginal bleeding,
• history of uterine fibroids,
• current pregnancy,
• known or suspected breast or uterine cancer,
• partial or complete hysterectomy
• Cardiac:
• myocardial infarction, ventricle tachycardia or fibrillation,
• angina,
• valvular disease,
• congestive heart failure, orthopnea, paroxysmal nocturnal dyspnea,
• current arrhythmias,
• prosthetic valves
• Pulmonary:

Sponsors & Collaborators

• Yale University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

John B. Pierce Laboratory

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Orthostatic Intolerance

Interventions

ganirelix; Estradiol; Progesterone

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners

Results Point of Contact

• Title: Nina Stachenfeld
• Organization: Yale School of Medicine

nina.stachenfeld@yale.edu

203-562-9901

Study Officials

• Nina Stachenfeld, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 30, 2010
• Study Start: February 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: December 13, 2018
• Results First Posted: January 30, 2017

Record last verified: 2018-11

Locations

US (1)