Clinical trial registration number: NCT00764881
ORIGINAL RESEARCH—WOMEN'S SEXUAL HEALTH
Change to Either a Nonandrogenic or Androgenic Progestin-Containing Oral Contraceptive Preparation is Associated with Improved Sexual Function in Women with Oral Contraceptive-Associated Sexual Dysfunction
Article first published online: 12 SEP 2013
© 2013 International Society for Sexual Medicine
The Journal of Sexual Medicine
Volume 10, Issue 12, pages 3069–3079, December 2013
How to Cite
Davis, S. R., Bitzer, J., Giraldi, A., Palacios, S., Parke, S., Serrani, M., Mellinger, U. and Nappi, R. E. (2013), Change to Either a Nonandrogenic or Androgenic Progestin-Containing Oral Contraceptive Preparation is Associated with Improved Sexual Function in Women with Oral Contraceptive-Associated Sexual Dysfunction. Journal of Sexual Medicine, 10: 3069–3079. doi: 10.1111/jsm.12310
Clinical trial registry: http://www.clinicaltrials.gov
- Issue published online: 2 DEC 2013
- Article first published online: 12 SEP 2013
- Estradiol Valerate;
- Ethinyl Estradiol;
- Oral Contraception;
- Female Sexual Dysfunction
It is a commonly held belief that combined oral contraceptive (COC) pills containing an androgenic progestin may be less likely to impair sexual function than COCs containing an anti-androgenic progestin.
The study aims to compare the effects of a COC containing a progestin with an anti-androgenic profile (estradiol valerate [E2V]/dienogest [DNG]) to that of one with an androgenic progestin (ethinyl estradiol [EE]/levonorgestrel [LNG]) on sexual function in women with COC-associated sexual dysfunction.
In this multicenter, randomized, double-blind, noninferiority study, women with COC-associated female sexual dysfunction (FSD) were randomized to E2V/DNG or EE/LNG for six cycles. The primary outcome was the change in the sum of Female Sexual Function Index (FSFI) desire and arousal component scores between baseline and cycle 6. Secondary outcome measures included changes to the FSFI domains, the Female Sexual Distress Scale (FSDS-R), Vaginal Health Assessment, the Atrophy Symptom Questionnaire, and the Psychological General Well Being Index over six treatment cycles.
Main Outcome Measure
The main outcome is the change in the sum of FSFI desire and arousal component scores between baseline and cycle 6.
Of 276 women screened, 213 received treatment and 191 completed the study. The mean increase in the sum of FSFI desire and arousal component scores was 5.90 (standard deviation [SD] 5.45) for E2V/DNG and 5.79 (SD 6.17) for EE/LNG (change from baseline P < 0.0001, both groups). Both treatments showed equal efficacy and were associated with improvements in all domains of the FSFI, with no between-group differences. Both COCs reduced the distress associated with FSD, as indicated by reduced FSDS-R scores.
In women with COC-associated FSD, switching to either E2V/DNG or EE/LNG was associated with equivalent improvements in symptoms, challenging the perception that COCs containing anti-androgenic progestins have a detrimental effect on sexual function relative to those containing androgenic progestins. Davis SR, Bitzer J, Giraldi A, Palacios S, Parke S, Serrani M, Mellinger U, and Nappi RE. Change to either a nonandrogenic or androgenic progestin-containing oral contraceptive preparation is associated with improved sexual function in women with oral contraceptive-associated sexual dysfunction. J Sex Med 2013;10:3069–3079.