Sex Hormones and Orthostatic Tolerance

NCT ID: NCT01153581

Last Updated: 2018-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2013-05-31

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.

Conditions

Orthostatic Intolerance

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Ganirelix acetate

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

Group Type: EXPERIMENTAL

Ganirelix acetate

Intervention Type: DRUG

Ganirelix acetate: .25 ml/day by subcutaneous injection

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.

Group Type: EXPERIMENTAL

17β-Oestradiol

Intervention Type: DRUG

17 beta estradiol: 0.2 mg/day (patches)

Progesterone

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

Group Type: EXPERIMENTAL

Progesterone

Intervention Type: DRUG

progesterone, 200 mg day-1 oral

Interventions

Ganirelix acetate

Ganirelix acetate: .25 ml/day by subcutaneous injection

Intervention Type: DRUG

17β-Oestradiol

17 beta estradiol: 0.2 mg/day (patches)

Intervention Type: DRUG

Progesterone

progesterone, 200 mg day-1 oral

Intervention Type: DRUG

Other Intervention Names

Antagon; 17 beta estradiol; estradiol; P4; Prometrium

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nina Stachenfeld, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

John B. Pierce Laboratory

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

2R01HL071159-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0512000875a

Identifier Type: -

Identifier Source: org_study_id