[Safety of promestriene capsule used in postmenopausal atrophic vaginitis].
OBJECTIVE
To investigate the safety and efficacy of promestriene capsule used in the treatment of postmenopausal atrophic vaginitis.


METHODS
Fifty-three women at age of 45 - 75 years (more than one year history of menopause) diagnosed with postmenopausal atrophic vaginitis were enrolled in self-control study. They all had typicalsymptoms of postmenopausal vaginitis. Promestriene was given by continuous therapy for 20 days, then maintenance therapy for for 8 weeks (1 pill two times per week used). The level of follicle stimulation hormone (FSH) and estradiol (E(2)) in serum was and thickness of endometrium were detected before and after treatment. The routine biochemical test was used as index to monitoring the safety. The vaginal mature index (VMI), the atrophic vaginitis evaluating score and vaginal healthy evaluating score were evaluated for therapeutic effect. In the mean time, adverse effect was recorded.


RESULTS
(1) SAFETY: during promestriene treatment, no case with adverse effect was observed. Before treatment, the mean level of FSH and E(2) was (71 +/- 3) U/L and (41 +/- 18) pmol/L, the mean thickness of endometrium was (2.4 +/- 0.9) mm. After treatment, the mean level of FSH and E(2) was (67 +/- 22) U/L and (43 +/- 37) pmol/L, the mean thickness of endometrium was (2.5 +/- 1.3) mm. No significant difference was observed (P > 0.05). (2) Therapeutic effect: VMI were 42 +/- 15 before and 54 +/- 8 after treatment. The atrophic vaginitis evaluating score were 3.4 +/- 1.7 before and 1.5 +/- 1.4 after treatment. Vaginal healthy evaluating score were 7.8 +/- 2.4 before and 12.0 +/- 2.4 after treatment. They all showed significant difference (P < 0.01). (3) Adverse effect: six cases with vaginal bleeding, 3 cases with breast nodules and 1 case with cervical polyp was observed, however, it was uncertain whether those events were associated with promestriene use.


CONCLUSIONS
The premestriene capsule was safe and effective in the treatment of postmenopausal atrophic vaginitis.
Sun
Ai-jun
AJ
Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
Lin
Shou-qing
SQ
Jing
Lian-hong
LH
Wang
Zi-yi
ZY
Ye
Jia-lin
JL
Zhang
Ying
Y
D000282:Administration, Intravaginal; D000368:Aged; D001284:Atrophy / Q000473:pathology; D002214:Capsules; D004958:Estradiol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D020249:Hormone Replacement Therapy / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause; D011788:Quality of Life; D016896:Treatment Outcome; D014621:Vagina / Q000187:drug effects* / Q000473:pathology; D014622:Vaginal Creams, Foams, and Jellies; D014627:Vaginitis / Q000188:drug therapy* / Q000473:pathology
D002214:Capsules; D014622:Vaginal Creams, Foams, and Jellies; D004958:Estradiol; C013657:promestriene