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Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study

M

Medimix Specialty Pharmacy, LLC

Status

Completed

Conditions

Menopause

Study type

Observational

Funder types

Industry

Identifiers

NCT01862861
Medimix Pharm-02

Details and patient eligibility

About

Bioidentical Hormone Replacement Therapy (BHRT) to assess a change in the number of various menopausal symptoms such as hot flashes and night sweats in surgically or naturally induced peri or post-menopausal women.

Full description

Participants will be receiving a customized bioidentical hormone regimen which may include a combination of estrogens, progesterone, and testosterone.

Enrollment

69 patients

Sex

Female

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants must be women who are in surgically or naturally induced menopause or perimenopause, as determined by their physician.
  • Participants must be starting a new regimen of bioidentical hormone replacement therapy.
  • Participants must be expected to receive therapy for at least 12 weeks.
  • Participants must be between 30 and 65 years of age.
  • Participants must be able to provide sound written informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf.

Exclusion criteria

  • Participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription.
  • Participants must not be pregnant or breastfeeding women.
  • Participants must not be managed outside the Medimix Specialty Pharmacy system with regard to their bioidentical hormone replacement therapy.
  • Participants must not be using another bioidentical hormone at the time of enrollment.

Trial design

69 participants in 1 patient group

Peri or post-menopausal women.
Description:
Women with peri or post-menopausal vasomotor symptoms between 30 and 60 years of age.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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