Journal article
Safety assessment of compounded non-FDA-approved hormonal therapy versus FDA-approved hormonal therapy in treating postmenopausal women
Menopause (New York, N.Y.), v 28(8), pp 867-874
01 Aug 2021
PMID: 33973545
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Objective: To assess the safety and serum estradiol (E-2) and total testosterone (T) concentrations in postmenopausal women treated with Pellet Hormonal Therapy (PHT) and Food and Drug Administration approved Hormonal Therapy (FHT). Methods: A total of 539 postmenopausal women were identified, including 384 on PHT and 155 on FHT. Data extracted from medical records include demographics, indication for hormone therapy, treatment duration, side effects, serum E-2 and T levels, and frequency of laboratory follow-up. Results: The incidence of overall side effects was significantly higher in PHT compared with FHT (221 [57.6%] vs 23 [14.8%], P < 0.00001, odds ratio [95% CI] =8.0[4.5-14.2]). When examining women with an intact uterus prior to hormone therapy initiation, 55.3% (136/246) on PHT vs 15.2% (12/79) on FHT had at least one episode of abnormal uterine bleeding (P < 0.0001, odds ratio [95% CI] = 7.9[3.6-17.0]). Furthermore, a significantly higher proportion of women on PHT (20.3% [50/246]), compared with 6.3% (5/79) on FHT, had a hysterectomy (P = 0.036, odds ratio [95% CI] = 3.2[1.1-9.3]). Both mean (SD, Min-Max) peak E-2 (pg/mL) and peak T (ng/dL) are significantly higher in the PHT group than those in the FHT group (E-2: 237.70 [168.55, 10-1,111] vs 93.45 [130.77, 5.5-465.8], T: 194.04 [84.94, 4.3-599] vs 15.59 [19.52, 0.2-70], P < 0.00001). Of those on PHT, four women had E-2 level > 1,000 pg/mL and nine women with T level > 400 ng/dL. Conclusion: Women on PHT had a significantly higher incidence of side effects than FHT as well as a significantly higher supraphysiological level of peak E-2 and T during the treatment.
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Details
- Title
- Safety assessment of compounded non-FDA-approved hormonal therapy versus FDA-approved hormonal therapy in treating postmenopausal women
- Creators
- Xuezhi Jiang - Drexel UniversityAnna Bossert - Reading HospitalK. Nathan Parthasarathy - Reading HospitalKristine Leaman - Reading HospitalShahab S. Minassian - Reading HospitalPeter F. Schnatz - Reading HospitalMark B. Woodland - Reading Hospital
- Publication Details
- Menopause (New York, N.Y.), v 28(8), pp 867-874
- Publisher
- Lippincott Williams & Wilkins
- Number of pages
- 8
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- MD (Doctor of Medicine) Program; Obstetrics and Gynecology
- Web of Science ID
- WOS:000678780400006
- Scopus ID
- 2-s2.0-85113149215
- Other Identifier
- 991019167583704721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Obstetrics & Gynecology