Clinical Trial
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Preliminary study on the effect of four-phasic estradiol valerate and dienogest (E2V/DNG) oral contraceptive on the quality of sexual life.

INTRODUCTION: A new oral contraceptive containing the natural estrogen estradiol and a 19-nortestosterone derivate dienogest (DNG) in a four-phasic 28-day regimen may be used by women.

AIM: To investigate the quality of sexual life of healthy women on estradiol valerate and DNG (E2V/DNG) oral contraceptive.

METHODS: Fifty-seven women (age range 18-48 years) were enrolled. The Short Form-36 (SF-36) questionnaire to assess quality of life (QoL) was administered at baseline and at the 26th day of both the 3rd and 6th cycles of oral contraceptive (OC) intake. The Short Personal Experience Questionnaire (SPEQ) to measure the change of sexual behavior was used at the 2nd, 7th, 14th, 21st, 26th, and 28th days of the baseline cycle, as well as at the same days of both the 3rd and 6th cycle of contraceptive intake.

MAIN OUTCOME MEASURE: The SF-36 and the SPEQ questionnaires.

RESULTS: Women reported QoL improvement at the 3rd (P < 0.05) and at the 6th cycles (P < 0.01). By SPEQ, improvement of sexuality during the 3rd and the 6th cycle with respect to baseline experience was observed (P < 0.05). The frequency of sexual activity remained basically unchanged (P = NS). Enjoyment and desire improved at the 6th cycle with respect to the 3rd cycle (P < 0.05). All women reported decreased dyspareunia at the 3rd and 6th cycles (P < 0.05). Interestingly, desire, arousal, orgasm, enjoyment, and sexual activity improved, reaching a peak around the 14th day of the menstrual cycle (P < 0.05). At the 3rd and 6th cycle, women on OCs were sexually cyclic, but the peak improvement of desire, arousal, orgasm, enjoyment, and sexual activity appeared around the 7th day of OC intake (P < 0.05).

CONCLUSION: Reduced hormone-free interval is a new concept in low-dose OC regimens. Moreover, the E2V/DNG multiphasic extended regimen has been found to positively modify the sexuality of users.

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