Search / Trial NCT00001322

The Effects of Reproductive Hormones on Mood and Behavior

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Nov 3, 1999

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Behavior Brain Function Progesterone Central Nervous System Function Gonadotropin Releasing Hormone (Gn Rh) Agonist

Description

Evidence suggests that the gonadal steroids may exert clinically significant effects on central nervous system function. For example, the menstrual cycle may influence the occurrence of seizures in some female epileptics and the performance on certain cognitive tests. Central nervous system effects of gonadal steroids have been inferred largely from changes in behavior occurring in association with presumed changes in gonadal steroids during the normal menstrual cycle, during the administration of ovarian hormones, or in a gender-specific context. These inferences are, by definition, indire...

Gender

Female

Eligibility criteria

  • INCLUSION CRITERIA:
  • Volunteers participating in this study will be women meeting the following criteria:
  • Between the ages of 18 and 50 years,
  • Not pregnant,
  • In good medical health,
  • Medication free,
  • No history of menstrual-related mood or behavioral disturbances.
  • Additionally, we will recruit a subsample of 20 asymptomatic women who will meet all inclusion and exclusion criteria in this protocol except they will have a history of a past major depressive episode.
  • Finally, a third sample of 10 women who meet all the inclusion and exclusion criteria listed above for this protocol will be recruited to establish the dose range of transdermal estrogen gel for this and related protocols (i.e., 90-M-0088 and 05-M-0059).
  • EXCLUSION CRITERIA:
  • The following conditions will constitute contraindications to treatment with hormonal therapy and will preclude a subject's participation in this protocol:
  • Current Axis I psychiatric diagnosis (with the exception of this women with a past major depression who will be studied on this protocol);
  • History consistent with endometriosis;
  • Diagnosis of ill-defined, obscure pelvic lesions, particularly undiagnosed ovarian enlargement;
  • Hepatic disease as manifested by abnormal liver function tests;
  • History of mammary carcinoma;
  • History of pulmonary embolism or phlebothrombosis;
  • Undiagnosed vaginal bleeding;
  • Porphyria;
  • Diabetes mellitus;
  • History of malignant melanoma;
  • Cholecystitis or pancreatitis;
  • Cardiovascular or renal disease;
  • Pregnancy;
  • Any woman meeting the Stages of Reproductive Aging Workshop Criteria (STRAW) for the perimenopause (129). Specifically, we will exclude any woman with an elevated plasma follicle stimulating hormone (FSH) level (greater than or equal to 14 IU/L) and with menstrual cycle variability of > 7 days different from their normal cycle length.
  • National Institute of Mental Health (NIMH) employees/staff and their immediate family members will be excluded from the study per NIMH policy.
  • Subjects taking birth control pills will be excluded from the study.
  • Subjects taking diuretics, prostaglandin inhibitors, or pyridoxine (putative treatments for MRMD) will similarly be excluded from the study, as will patients taking psychotropic agents (e.g., lithium carbonate, tricyclic antidepressants).
  • All subjects will be required to use non-hormonal forms of birth control (e.g., barrier methods) to avoid pregnancy during this study.
  • Participants who have an active condition that places them at an increased risk for osteoporosis will be excluded from this protocol.

Attachments

readout_NCT00001322_2024-05-23.pdf

4.5 MB

NCT00001322_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Phase 1: Weeks 6 and 8 or 10 and 12; Phase 2: Weeks 2 and 4 of estradiol or progesterone

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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