Abstract | OBJECTIVES: 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.
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Authors | Pedro-Antonio Regidor, Enrico Colli, Santiago Palacios |
Journal | Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology
(Gynecol Endocrinol)
Vol. 37
Issue 12
Pg. 1121-1127
(Dec 2021)
ISSN: 1473-0766 [Electronic] England |
PMID | 34402728
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article)
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Chemical References |
- Androstenes
- Contraceptives, Oral, Hormonal
- Mineralocorticoid Receptor Antagonists
- Desogestrel
- drospirenone
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Topics |
- Adult
- Androstenes
(administration & dosage, adverse effects)
- Contraceptives, Oral, Hormonal
(administration & dosage, adverse effects)
- Desogestrel
(administration & dosage, adverse effects)
- Double-Blind Method
- Female
- Humans
- Medication Adherence
- Mineralocorticoid Receptor Antagonists
(administration & dosage, adverse effects)
- Prospective Studies
- Uterine Hemorrhage
(chemically induced)
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