Efficacy and safety of vaginal estriol and progesterone in postmenopausal women with atrophic vaginitis.
OBJECTIVE
The aim of this study was to assess the efficacy and safety of intravaginal estriol and progesterone on atrophic vaginitis in postmenopausal women.


METHODS
Under a physician-sponsored Investigational New Drug application, 19 healthy postmenopausal women with atrophic vaginitis received vaginal suppositories containing estriol (1 mg) and progesterone (30 mg). The participants were instructed to insert one suppository intravaginally once daily for 2 weeks and thrice weekly for a total of 6 months. Vaginal pH, Vaginal Maturation Index, urinalysis, self-reported vaginal dryness, menopausal quality of life, and serum estriol and progesterone levels were measured at enrollment and after 3 and 6 months of suppository use. Endometrial biopsies were obtained at enrollment and at 6 months. After 2 weeks of therapy, six participants had serum estriol and progesterone measured.


RESULTS
The Vaginal Maturation Index, vaginal pH, and vaginal dryness rating improved significantly at 3 and 6 months compared with baseline. Menopausal quality of life scores improved significantly in all domains, with the sexual subscale showing the most improvement. There were no cases of endometrial hyperplasia after 6 months of suppository use. Serum preinsertion estriol at week 2 and months 3 and 6 were similar to baseline levels. Serum preinsertion progesterone increased but returned to baseline preinsertion levels at month 6, and preinsertion levels were significantly less at month 6 compared with month 3.


CONCLUSIONS
Intravaginal administration of a combination estriol and progesterone agent to women with atrophic vaginitis may represent a safe and effective alternative to systemic hormone replacement, although this study was not adequate to provide proof of efficacy given that it was uncontrolled.
Chollet
Janet A
JA
Beth Israel Deaconess Medical Center, Boston, MA, USA. chollet.j@gmail.com
Carter
Gloria
G
Meyn
Leslie A
LA
Mermelstein
Fred
F
Balk
Judith L
JL
D000282:Administration, Intravaginal; D000368:Aged; D001284:Atrophy; D004359:Drug Therapy, Combination; D004964:Estriol / Q000097:blood / Q000627:therapeutic use*; D015914:Estrogen Replacement Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D010865:Pilot Projects; D017698:Postmenopause / Q000187:drug effects* / Q000502:physiology / Q000523:psychology; D011374:Progesterone / Q000097:blood / Q000627:therapeutic use*; D011788:Quality of Life / Q000523:psychology; D012449:Safety; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014621:Vagina / Q000187:drug effects / Q000473:pathology; D014627:Vaginitis / Q000097:blood / Q000188:drug therapy* / Q000209:etiology
D011374:Progesterone; D004964:Estriol