Overall and bleeding-related discontinuation rates of a new oral contraceptive containing 4 mg drospirenone only in a 24/4 regimen and comparison to 0.075 mg desogestrel.
Gynecol Endocrinol
; 37(12): 1121-1127, 2021 Dec.
Article
em En
| MEDLINE
| ID: mdl-34402728
OBJECTIVES: Progestin-only pills do not increase the risk of venous thromboembolism, stroke, and myocardial infarction but are associated with poor cycle control. A novel estrogen-free pill containing only drospirenone (DRSP) to improve bleeding patterns and tolerability and reduce discontinuation rates has been introduced into the market. The present study aims to describe the improvement in the acceptability of this DRSP-only pill, e.g. regarding the bleeding profile and the reduction in discontinuation rates due to unacceptable bleeding compared to desogestrel (DSG). STUDY DESIGN: Double-blind, double-dummy prospective phase III study in healthy women aged 18-45 years evaluating a total of 858 women with 6691 DRSP and 332 women with 2487 DSG treatment cycles. RESULTS: Overall, 82 (9.6%) women in the DRSP group and 44 (13.3%) women in the DSG group experienced treatment-emergent adverse events (TEAEs) leading to premature termination of the trial meaning that 32% more women in the DRSP group finished the trial in comparison to the DSG group (based on the AUC of Kaplan-Meier's curves). Discontinuation rates due to abnormal bleeding were 3.7% for DRSP and 7.3% for DSG users. This is a 55.7% lower discontinuation rate in the DRSP group compared to the DSG group. CONCLUSIONS: This report describes the improvement in acceptability and bleeding profile of women using the new DRSP-only oral contraceptive compared to DSG, providing a better quality of life and adherence to the contraceptive method as demonstrated by lower discontinuation rates of women using the estrogen-free DRSP-only pill.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Hemorragia Uterina
/
Desogestrel
/
Anticoncepcionais Orais Hormonais
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Antagonistas de Receptores de Mineralocorticoides
/
Androstenos
Tipo de estudo:
Clinical_trials
/
Observational_studies
Limite:
Adult
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Female
/
Humans
Idioma:
En
Revista:
Gynecol Endocrinol
Assunto da revista:
ENDOCRINOLOGIA
/
GINECOLOGIA
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Alemanha