Women's Health Research Program, School of Public Health and Preventive Medicine, Monash University, Melbourne, Vic., Australia.
J Sex Med. 2013 Dec;10(12):3069-79. doi: 10.1111/jsm.12310. Epub 2013 Sep 12.
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 [E2 V]/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 E2 V/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.
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 E2 V/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 E2 V/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.
人们普遍认为，含有雄激素孕激素的复方口服避孕药（COC）可能比含有抗雄激素孕激素的 COC 更不容易损害性功能。
本研究旨在比较孕激素具有抗雄激素作用（戊酸雌二醇[E2V]/地诺孕素[DNG]）与孕激素具有雄激素作用（炔雌醇[EE]/左炔诺孕酮[LNG]）的 COC 对 COC 相关性功能障碍女性性功能的影响。
在这项多中心、随机、双盲、非劣效性研究中，患有 COC 相关女性性功能障碍（FSD）的女性被随机分配至 E2V/DNG 或 EE/LNG 组，共进行 6 个周期。主要结局是从基线到第 6 个周期时女性性健康指数（FSFI）欲望和唤起分量表总分的变化。次要结局指标包括 FSFI 各领域、女性性困扰量表（FSDS-R）、阴道健康评估、萎缩症状问卷和心理一般健康指数在 6 个治疗周期中的变化。
主要结局是从基线到第 6 个周期时 FSFI 欲望和唤起分量表总分的变化。
在 276 名接受筛查的女性中，213 名接受了治疗，191 名完成了研究。E2V/DNG 组 FSFI 欲望和唤起分量表总分的平均增加量为 5.90（标准差[SD]5.45），EE/LNG 组为 5.79（SD6.17）（与基线相比，P<0.0001，两组均）。两种治疗方法均显示出同等疗效，并与 FSFI 所有领域的改善相关，两组间无差异。两种 COC 均降低了与 FSD 相关的痛苦，表现为 FSDS-R 评分降低。
在 COC 相关 FSD 的女性中，转换为 E2V/DNG 或 EE/LNG 与症状的等效改善相关，这挑战了含有抗雄激素孕激素的 COC 对性功能的影响相对于含有雄激素孕激素的 COC 更具损害性的观点。
