NCT01862861

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

8 months

First QC Date

May 22, 2013

Last Update Submit

July 30, 2014

Conditions

Menopause

Keywords

Bioidentical Hormone Replacement Therapy

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy of bioidentical hormone replacement therapy in decreasing the severity of vasomotor symptoms.

    The reduction of severity of vasomotor symptoms will be evaluated by utilizing the Menopause Rating Scale (MRS) from baseline to the end of study at 12 weeks.

    12 Week Study

Secondary Outcomes (1)

  • To evaluate health-related quality of life (HrQol)

    12 Weeks

Study Arms (1)

Peri or post-menopausal women.

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

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Peri-menopausal or post-menopausal women between the age of 30 and 65 years of age.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Medimix Specialty Pharmacy, LLC

Jacksonville, Florida, 32216, United States

Location

Related Publications (14)

  • Wepfer ST. The science behind hormone replacement therapy, part ! Int J Pharm Compd. 2001 Nov-Dec;5(6):462-4. No abstract available.

    PMID: 23982041BACKGROUND

  • Holtorf K. The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? Postgrad Med. 2009 Jan;121(1):73-85. doi: 10.3810/pgm.2009.01.1949.

    PMID: 19179815BACKGROUND

  • Lorentzen J. Hormone replacement therapy: part 1 - the evolution of hormone treatment. Int J Pharm Compd. 2001 Sep-Oct;5(5):336-8. No abstract available.

    PMID: 23981968BACKGROUND

  • Ruiz AD, Daniels KR, Barner JC, Carson JJ, Frei CR. Effectiveness of compounded bioidentical hormone replacement therapy: an observational cohort study. BMC Womens Health. 2011 Jun 8;11:27. doi: 10.1186/1472-6874-11-27.

    PMID: 21651797BACKGROUND

  • Thurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health across the Nation. Obstet Gynecol Clin North Am. 2011 Sep;38(3):489-501. doi: 10.1016/j.ogc.2011.05.006.

    PMID: 21961716BACKGROUND

  • Gold EB, Colvin A, Avis N, Bromberger J, Greendale GA, Powell L, Sternfeld B, Matthews K. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. Am J Public Health. 2006 Jul;96(7):1226-35. doi: 10.2105/AJPH.2005.066936. Epub 2006 May 30.

    PMID: 16735636BACKGROUND

  • Levin ER, Hammes SR.Chapter 40. Estrogens and Progestins. In: Chabner BA, Bruton LL, Knollman BC, eds. Goodman & Gilman's The Pharmacological Basis of Therapeutics. 12nd ed. New York: McGraw-Hill; 2011. http://www.accesspharmacy.com/content.aspx?aID=16673417. Accessed September 28, 2012

    BACKGROUND

  • Snyder PJ. Chapter41. Androgens. In: Chabner BA, Bruton LL, Knollman BC, eds. Goodman & Gillman's The Pharmacological Basis of Therapeutics. 12nd ed. New York: McGraw-Hill; 2011. http;//www.accesspharmacy.com/content.aspx?aID=16673856. Accessed September 28,2012.

    BACKGROUND

  • Maclennan AH, Broadbent JL, Lester S, Moore V. Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flushes. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD002978. doi: 10.1002/14651858.CD002978.pub2.

    PMID: 15495039BACKGROUND

  • Heinemann LA, DoMinh T, Strelow F, Gerbsch S, Schnitker J, Schneider HP. The Menopause Rating Scale (MRS) as outcome measure for hormone treatment? A validation study. Health Qual Life Outcomes. 2004 Nov 22;2:67. doi: 10.1186/1477-7525-2-67.

    PMID: 15555079BACKGROUND

  • Hunter MS, The Women's Health Questionnaire (WHQ): the development, standardization and application of a measure of mid-aged women's emotional and physical health. Quality of Life Res. 2000;9(1):733-738.

    BACKGROUND

  • Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2012.

    BACKGROUND

  • Julious SA, Campbell MJ. Sample size calculations for paired or matched ordinal data. Stat Med. 1998 Jul 30;17(14):1635-42. doi: 10.1002/(sici)1097-0258(19980730)17:143.0.co;2-k.

    PMID: 9699235BACKGROUND

  • Julious SA, Campbell MJ, Altman DG. Estimating sample sizes for continuous, binary, and ordinal outcomes in paired comparisons: practical hints. J Biopharm Stat. 1999 May;9(2):241-51. doi: 10.1081/BIP-100101174.

    PMID: 10379691BACKGROUND

Study Officials

  • Benjamin J Epstein, PharmD

    The Medimix Specialty Pharmacy, LLC

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2013

First Posted

May 27, 2013

Study Start

November 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 31, 2014

Record last verified: 2014-07

Locations

US(1)