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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Sex Hormones and Orthostatic Tolerance

NCTNCT01153581 (opens ClinicalTrials.gov in a new tab)Other id0512000875aOther id2R01HL071159-04
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
109 participants (actual)
Sponsor
Yale University · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Feb 2006
Primary completion
Dec 2012
Completion
May 2013
First posted
30 Jun 2010 (estimated)
Last update posted
13 Dec 2018
Conditions
Orthostatic Intolerance

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20062008201020122014
  1. Ph 2

    Sex Hormones and Orthostatic Tolerance

    NCT01153581

    Feb 2006 to May 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Ganirelix acetateDrug
  • 17β-OestradiolDrug
  • ProgesteroneDrug

Arms3

  • Experimental

    Ganirelix acetate

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

  • Experimental

    17β-Oestradiol, E2

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

  • Experimental

    Progesterone

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

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Orthostatic Tolerance

    Time frame · 2 months

    Registry description

    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. Baroreceptor Function

    Time frame · 2 months

    Registry description

    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.

  3. Skin Microvascular Responses

    Time frame · 2 months

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 2 months

Orthostatic Tolerance

GroupValue (mmHg*min)Spread
Women With and Without Orthostatic Intolerance634213
Primary outcomeMean· 2 months

Baroreceptor Function

GroupValue (ms/mm Hg)Spread
Low Orthostatic Tolerance0.1400.034
High Orthostatic Tolerant0.1280.044
Primary outcomeMean· 2 months

Skin Microvascular Responses

GroupValue (Percent of max volts)Spread
Women With Orthostatic Intolerance4.020.39
Women Without Orthostatic Tolerance5.180.31

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Ganirelix AcetateGanirelix acetate (Organon, Roseland, NJ, USA), a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotrophin-releasing hormone (GnRH) to suppress GnRH. (250 μg in 0.5ml normal saline for 16 days).–0 / 1090 / 109
17β-OestradiolThe same women added 17β-Oestradiol, E2; 0.2 mg day-1 patch (Vivelle; CIBA Pharmaceuticals, Summit, NJ) for days 4-16.–0 / 1090 / 109
ProgesteroneThe same women added progesterone (P4, 200 mg day-1 Prometrium, oral, Solvay Pharmaceuticals, Marietta, GA, USA) on days 13-16.–0 / 1090 / 109

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 34 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy, English-speaking non-smoking women age 18- 34 with regular menses Exclusion Criteria: * Gynecologic: 1. current or past estrogen-dependent neoplasia, 2. unexplained vaginal bleeding, 3. history of uterine fibroids, 4. current pregnancy, 5. known or suspected breast or uterine cancer, 6. partial or complete hysterectomy * Cardiac: 1. myocardial infarction, ventricle tachycardia or fibrillation, 2. angina, 3. valvular disease, 4. congestive heart failure, orthopnea, paroxysmal nocturnal dyspnea, 5. current arrhythmias, 6. prosthetic valves * Pulmonary: 1. current cigarette smokers, or pipe or cigar smokers, 2. chronic obstructive pulmonary disease, 3. adult asthma, 4. dyspnea on exertion, 5. current bronchitis, pneumonia, or tuberculosis, 6. lung carcinoma, 7. pulmonary embolus, recent * Vascular: 1. claudication or history of peripheral vascular disease, 2. abdominal or thoracic aortic aneurysm, or repair of same, 3. cerebral aneurysm, vascular malformations, 4. hypertension, systolic or diastolic, or strong family history of hypertension * Gastrointestinal: 1. GI malignancy, 2. hepatitis, current, 3. splenomegaly from any cause, 4. Cholecystitis, 5. current diverticulosis or diverticulitis, inflammatory bowel disease, ulcerative colitis, Crohn's Disease, 6. previous gastrointestinal surgery * Infectious Disease: any intercurrent infection * Hematologic/Oncologic: 1. receiving chemotherapy or radiation therapy, 2. any metastatic malignancy, 3. anemia (hematocrit \< 35), 4. thrombocytopenia or thrombocytosis, 5. neutropenia, 6. hematologic malignancy, 7. bleeding dyscrasia * Neurologic: 1. history of cerebral vascular accident with any neurologic sequels, 2. uncontrolled seizures (e.g. more than 1 seizure/year), 3. transient ischemic attacks, 4. dementia, 5. neurologic conditions producing dyscoordination, peripheral neuropathy, or myopathy, 6. severe migraine headaches * Endocrine: 1. diabetes mellitus, 2. any untreated endocrinopathy * Renal: 1. chronic renal disease, 2. any history of renal disease or impairment, 3. current urinary tract infection * Musculoskeletal: 1. inflammatory arthritis history (e.g., rheumatoid, psoriatic, Reiters), 2. any history of pathologic fractures, including vertebral compression fractures * Pharmacologic: 1. any illegal drug use, 2. alcohol use greater than an average of 4 oz/day over 30 days, 3. coumadin or heparin use, 4. current systemic antifungal use

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