Clinical Trials and Therapeutics

Clinical Pharmacology & Therapeutics (1998) 64, 204–210; doi:

The use of two estrogen preparations (a combined contraceptive pill versus conjugated estrogen cream) intravaginally to treat urogenital symptoms in postmenopausal Thai women: A comparative study*

Sumana Chompootaweep MD1, Pongpun Nunthapisud MSc1, Prasert Trivijitsilp MD1, Prasertsri Sentrakul MD1 and Nikorn Dusitsin MD1

1Department of Pharmacology, the Department of Microbiology, and the Department of Obstetrics and Gynaecology Faculty of Medicine, and the Institute of Health Research, Chulalongkorn University, and the BNH Hospital, Bangkok, Thailand.

Correspondence: Sumana Chompootaweep, MD, Department of Pharmacology, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.

*Supported by a grant from the Rhatchada-Pisakesompoj Fund, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

Received 20 November 1997; Accepted 11 March 1998.

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Abstract

Objective: To determine whether the combined contraceptive pill used intravaginally was as effective as the standard conjugated estrogen cream for the treatment of urogenital symptoms in postmenopausal Thai women.

Subjects and Methods: In a randomized clinical trial, 40 postmenopausal women with urogenital symptoms were randomly allocated to two treatment groups for 8 weeks. The first group (n = 20) received a combined contraceptive pill by the vaginal route, one tablet per week at bedtime for 8 weeks. Each tablet contained 250 mug levonorgestrel plus 30 mug ethinyl estradiol. The second group (n = 20) was given 1 gm of an intravaginal conjugated estrogen cream at bedtime, three times in the first week, twice in the second week, and then once a week for the next 6 weeks (1 gram of conjugated estrogen cream contained 0.625 mg conjugated equine estrogens). Subjects were questioned about their urogenital symptoms, and vaginal cytologic smears, vaginal bacterial cultures, and urine cultures were performed before treatment and after 2, 4, and 8 weeks of therapy.

Results: The vaginal pH and the proportion of the fecal type bacteria decreased in both groups, with no statistically significant difference between the groups. The karyopyknotic index and the maturation index were improved during treatment in both groups. An increase in the proportion of lactobacilli were recorded in both groups after therapy, with no significant difference between the two groups. No significant changes were observed in urinary bacteria. The therapy (combined contraceptive pill and estrogen cream) had a marked effect on urogenital symptoms (vaginal dryness, dyspareunia, urinary frequency, and urinary urgency), with impressive improvement comparably in both groups.

Conclusions: A combined contraceptive tablet administered vaginally once a week can alleviate urogenital symptoms in Thai postmenopausal women as effectively as the vaginal estrogen cream. However, the pills are much less expensive and are easily obtained in developing countries.

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