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UBC Theses and Dissertations
Phase II 6-month cyclic progesterone/spironolactone pilot therapy trial in polycystic ovary syndrome—a pre-post one-arm feasibility study Nelson, Kaitlin
Abstract
Background: Polycystic ovary syndrome (PCOS) is a common endocrine disorder that significantly impacts quality of life. Existing treatments often fail to address root causes or meet primary concerns of affected individuals. This study evaluated the feasibility and impact of a 6-month treatment with cyclic progesterone and spironolactone on health-related quality of life in women with androgenic PCOS. Methods: A 6-month open-label, pre-post pilot study was conducted with 26 participants (mean age 29 ± 4.9 years, BMI 30.3 ± 8.1 kg/m², 61.5% White). Within-woman changes assessed using the PCOS-specific quality of life questionnaire (PCOSQ), acne severity, and sleep quality. Demographic, socioeconomic, comorbidities, lifestyle variables, and biochemical measures were analyzed. Results: Significant improvements were observed in the total PCOSQ score, increasing from 3.5 ± 1.0 (95% CI: 3.1; 3.8) at baseline to 4.9 ± 1.1 (95% CI: 4.6; 5.3) at 6 months (t(25) = -6.56, P = .0000007). All domains showed enhancements: emotional well-being (3.5 ± 1.2, 95% CI: 3.0; 3.9, IQR = 1.8) to 5.0 ± 1.4 (95% CI: 4.5; 5.6, IQR = 1.9) (Z = -4.0, P = .000009); body hair concerns (4.0 ± 1.8, 95% CI: 3.2; 4.7, IQR = 3.4) to 5.4 ± 1.4 (95% CI: 4.8; 5.9, IQR = 1.6) (Z = -4.4, P = .00003); weight concerns (2.6 ± 1.8, 95% CI: 1.8; 3.3, IQR = 2.1) to 4.2 ± 2.0 (95% CI: 3.4; 4.5, IQR = 3.6) (Z = -4.1, P = .0001); infertility-related distress (3.9 ± 1.5, 95% CI: 3.3; 4.5, IQR = 1.9) to 5.3 ± 1.4 (95% CI: 4.7; 5.9, IQR = 1.5) (Z = -4.1, P = .00005); and menstrual concerns (3.6 ± 1.1, 95% CI: 3.2; 4.1, IQR = 1.2) to 4.9 ± 1.4 (95% CI: 4.3; 5.4, IQR = 1.5) (Z = -3.5, P = .0009). Perceived acne severity and sleep quality also significantly improved. Conclusions: Cyclic progesterone and spironolactone showed potential as effective treatment options for improving quality of life in women with androgenic PCOS, addressing multiple symptoms. These findings support further research and suggest the need for randomized trials comparing cyclic progesterone/spironolactone to standard-of-care combined hormonal contraception.
Item Metadata
Title |
Phase II 6-month cyclic progesterone/spironolactone pilot therapy trial in polycystic ovary syndrome—a pre-post one-arm feasibility study
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Creator | |
Supervisor | |
Publisher |
University of British Columbia
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Date Issued |
2024
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Description |
Background: Polycystic ovary syndrome (PCOS) is a common endocrine disorder that significantly impacts quality of life. Existing treatments often fail to address root causes or meet primary concerns of affected individuals. This study evaluated the feasibility and impact of a 6-month treatment with cyclic progesterone and spironolactone on health-related quality of life in women with androgenic PCOS.
Methods: A 6-month open-label, pre-post pilot study was conducted with 26 participants (mean age 29 ± 4.9 years, BMI 30.3 ± 8.1 kg/m², 61.5% White). Within-woman changes assessed using the PCOS-specific quality of life questionnaire (PCOSQ), acne severity, and sleep quality. Demographic, socioeconomic, comorbidities, lifestyle variables, and biochemical measures were analyzed.
Results: Significant improvements were observed in the total PCOSQ score, increasing from 3.5 ± 1.0 (95% CI: 3.1; 3.8) at baseline to 4.9 ± 1.1 (95% CI: 4.6; 5.3) at 6 months (t(25) = -6.56, P = .0000007). All domains showed enhancements: emotional well-being (3.5 ± 1.2, 95% CI: 3.0; 3.9, IQR = 1.8) to 5.0 ± 1.4 (95% CI: 4.5; 5.6, IQR = 1.9) (Z = -4.0, P = .000009); body hair concerns (4.0 ± 1.8, 95% CI: 3.2; 4.7, IQR = 3.4) to 5.4 ± 1.4 (95% CI: 4.8; 5.9, IQR = 1.6) (Z = -4.4, P = .00003); weight concerns (2.6 ± 1.8, 95% CI: 1.8; 3.3, IQR = 2.1) to 4.2 ± 2.0 (95% CI: 3.4; 4.5, IQR = 3.6) (Z = -4.1, P = .0001); infertility-related distress (3.9 ± 1.5, 95% CI: 3.3; 4.5, IQR = 1.9) to 5.3 ± 1.4 (95% CI: 4.7; 5.9, IQR = 1.5) (Z = -4.1, P = .00005); and menstrual concerns (3.6 ± 1.1, 95% CI: 3.2; 4.1, IQR = 1.2) to 4.9 ± 1.4 (95% CI: 4.3; 5.4, IQR = 1.5) (Z = -3.5, P = .0009). Perceived acne severity and sleep quality also significantly improved.
Conclusions: Cyclic progesterone and spironolactone showed potential as effective treatment options for improving quality of life in women with androgenic PCOS, addressing multiple symptoms. These findings support further research and suggest the need for randomized trials comparing cyclic progesterone/spironolactone to standard-of-care combined hormonal contraception.
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Genre | |
Type | |
Language |
eng
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Date Available |
2025-01-06
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Provider |
Vancouver : University of British Columbia Library
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Rights |
Attribution-NonCommercial-NoDerivatives 4.0 International
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DOI |
10.14288/1.0447691
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URI | |
Degree | |
Program | |
Affiliation | |
Degree Grantor |
University of British Columbia
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Graduation Date |
2025-05
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Campus | |
Scholarly Level |
Graduate
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DSpace
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Rights
Attribution-NonCommercial-NoDerivatives 4.0 International