Efficacy and Safety of Drospirenone 3 mg and Ethinylestradiol 20 mcg in a 24-4 Regimen

6 Nov, 10

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Efficacy and Safety of a Low-Dose Combined Oral Contraceptive Containing Drospirenone 3 mg and Ethinylestradiol 20 mcg in a 24/4-Day Regimen

Aim

To assess the efficacy, safety and user satisfaction associated with Drsp 3 mg/EE 20 mcg (D+EE) in a 24/4-day regimen in non-obese women.

An open-label. Phase III study performed at 50 centers in Europe
Inclusion criteria
- 1101 healthy female volunteers, with a BMI < 30 kg/m², aged between 18 and 35 years, who were at risk of pregnancy (sexually active) and who had requested contraception were included
Treatment period
- D+EE was given for 24 consecutive days followed by 4 hormone-free days for 13 cycles
- For both OC switchers and starters, the 1st tablet was to be taken on the first day of withdrawal bleeding or menses, counted as Day 1 of the first medication cycle.
Women were assessed during Cycles 1, 3, 6 and 9, HCG-urine pregnancy tests results were collected, vital signs and body weight were measured, adverse events (AEs) were recorded.

Contraceptive efficacy
- Adjusted Pearl Index for perfect use = 0.22
Compliance
- High compliance throughout the study
- Very high continuation rate - 87%
Satisfaction with treatment
- Satisfaction - 85.6% were satisfied or very satisfied
- Emotional and physical well-being - >85% of women reported improvement or no change
- Preferred method - 83.1% of women preferred hormonal contraception for future contraception
- Future method of choice - 70.4%
Safety
- Majority of AEs
  - Were mild to moderate in intensity
  - Resolved or were resolving by the study endpoint
  - Were typical of those associated with hormonal contraceptive use
- No venous thromboembolism cases reported during the study
- No AEs consistent with high potassium levels reported

D+EE was associated with
- A high rate of contraceptive reliability
- High compliance-to-treatment rate
- An acceptable safety profile
- Positive effect on both emotional and physical well-being

Contraception. 2009;80(1):18-24

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