The aim of this study was to assess the efficacy and safety of intravaginal estriol and progesterone on atrophic vaginitis in postmenopausal women.
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.
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.
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.
Intravaginal administration of a combination of estriol and progesterone to women who have atrophic vaginitis may represent a safe and effective alternative to systemic hormone therapy.
From the 1Beth Israel Deaconess Medical Center, Boston, MA; 2University of Pittsburgh Medical Center, Pittsburgh, PA; and 3Peartree Women's Healthcare, Cambridge, MA.
Received October 10, 2008; revised and accepted January 8, 2009.
Funding/support: Financial support was provided by Pear Tree Pharmaceuticals.
Financial disclosure/conflicts of interest: Dr. Chollet reports equity and employment with Pear Tree Pharmaceuticals, Dr. Balk reports equity with Pear Tree Pharmaceuticals and Dr. Mermelstein reports equity with Pear Tree Pharmaceuticals.
Address correspondence to: Janet A. Chollet, MD, Pear Tree Pharmaceuticals, 125 Cambridge Park Drive, Cambridge, MA 02140. E-mail: firstname.lastname@example.org