Cyclic progesterone and spironolactone treatment for androgenic polycystic ovary syndrome
PCOS > Treatment > Cyclic Progesterone TherapyPCOS > Treatment > Anti-Androgen TherapyRRM Methods > Hormonal Treatment > Progesterone Protocols
"Phase II 6-month Cyclic Progesterone/Spironolactone pilot Therapy Trial in Polycystic Ovary Syndrome : pre-post, single-arm feasibility study"
- University of British Columbia, Vancouver, BC, Canada ROR
- Vancouver Hospital and Health Sciences Centre ROR
- University of British Columbia Hospital ROR
Open Collections
Abstract
Androgenic Polycystic Ovary Syndrome (PCOS) creates physical/emotional burdens in 4-20% of premenopausal women living with PCOS (WLWP) including: few menstruations per year, subfertility, hirsutism/acne and low quality of life by validated PCOS Questionnaire (PCOSQ). Combined hormonal contraceptives (CHC), the current standard-of-care, improve PCOSQ only 16%; with stopping CHC, benefits disappear within 6-months. We hypothesize too-fast brain/luteinizing hormone (LH) pulses cause PCOS. Progesterone (P4) slows LH when testosterone (FreeT) is normal. Combining two approved medications, Cyclic P4 with anti-androgen, Spironolactone (Sp), will likely provide effective, durable benefits. WLWP lit-review suggested significant P4 7-14-day benefits. A 6-month prospective feasibility study of CyclicP4/Sp is necessary. Overall
Purpose
Perform a pilot study in 40 WLWP on Cyclic P4 (300 mg/bedtime, 14 days/month) plus Spironolactone (Sp, 200 mg/d). Feasibility: Assess longitudinal within-WLWP 6-month changes in: 1) PCOSQ; 2) FreeT, HbA1c, and LH; plus 3) WLWP's acceptance of CyclicP4/Sp.
Methods
Single-centre, prospective, longitudinal single cohort study. Recruit ~7-8 WLWP/month over 4-6 months; 85% retention. Eligible WLWP have physician-diagnosed PCOS, are 1-month off CHC/metformin, ages 19-35 (avoiding adolescence/perimenopause), HbA1c <6.4% (no diabetes) and commit to non-hormonal contraception, if needed. Recruitment uses online, internet, strategic ads and tear-tab posters. Measures at 0 and 6 months: as above plus K+ (safety assessment). Menstrual Cycle Diary monitoring (flow, adherence), 2 visits, monthly telephone/emails for support and assessment of any adverse effects. Statistical analysis: changes by paired T-test.
Summary
A feasibility 6-month study of CyclicP4/Sp will facilitate a CIHR-funded RCT of CHC versus this innovative and likely beneficial treatment for WLWP.
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Cite this article
Prior, J. C., Singer, J., Goshtasebi, A., Dahl, M., Shirin, S., Kalidasan, D., Murray, F., Yip, J., & Nelson, K. (2021). Phase II 6-month Cyclic Progesterone/Spironolactone pilot Therapy Trial in Polycystic Ovary Syndrome : pre-post, single-arm feasibility study. *Open Collections*. https://doi.org/10.14288/1.0396377
Prior JC, Singer J, Goshtasebi A, Dahl M, Shirin S, Kalidasan D, et al. Phase II 6-month Cyclic Progesterone/Spironolactone pilot Therapy Trial in Polycystic Ovary Syndrome : pre-post, single-arm feasibility study. Open Collections. 2021. doi:10.14288/1.0396377
Prior, J. C., et al. "Phase II 6-month Cyclic Progesterone/Spironolactone pilot Therapy Trial in Polycystic Ovary Syndrome : pre-post, single-arm feasibility study." *Open Collections*, 2021.