Several studies have shown that vaginal delivery of hormones, including estriol, estradiol, estrone, progesterone and testosterone leads to decent system absorption. It has also been shown that hormones applied to the mucous membranes are more readily absorbed than hormones applied to the skin.
However, there is lack of evidence to support vaginal application of a combination hormone-containing cream for local and systemic relief. A pilot study was carried out by Karger to examine the extent of absorption of a single cream containing estriol, estradiol, progesterone, DHEA, and testosterone.
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The study involved the participation of 12 postmenopausal women in the age group of 49 to 74 years. Baseline hormone levels of the participants were obtained.
In the first phase of the study, the patients were instructed to apply a compounded hormone cream with a combination of estriol, estradiol, progesterone, DHEA, and testosterone.
The cream was applied to the mucous membranes of the labia and vagina each morning using the index finger. Serum and saliva hormonal levels were recorded at pre-determined intervals during the study.
Results of Phase One
Estradiol and free estradiol were elevated in serum and saliva at the end of the study. Progesterone levels also increased in serum and saliva. Serum free testosterone was elevated at 6 h and correlated with relief of symptoms related to low testosterone levels.
Phase Two and its Results
In the second phase of the study, the dose of compounded cream medication was increased. Patient satisfaction with cream-based delivery method was high. Vaginal delivery of hormones provided relief of systemic symptoms along with relief of vaginal and urinary symptoms. 87 percent of patients in the study had genital urinary symptoms before therapy and all patients had relief of these symptoms with therapy at day 28.
All 12 patients chose to continue with the cream-based therapy, which may indicate a patient preference for this convenient treatment versus choosing no treatment. This pilot study documented the systemic absorption of multiple hormones by both saliva and blood testing as well as relief symptoms.
The combination cream utilized in this pilot study may be applied intravaginally, to the external mucous membranes, or both. Based on the results, the absorption is adequate with either application site and patients generally tolerated this method of administration with a high level of satisfaction.
Vaginal hormone therapy has been successfully used in practice by the authors of the study for more than five years in about 2,000 patients with excellent clinical outcomes. Current dosing, which relieves local and systemic symptoms without noted side effects, is estriol 0.5 mg, estradiol 0.1 mg, progesterone 25 mg, and testosterone 0.5 mg in a 0.25 ml volume of non-irritating cream base three to six days a week. Vaginal delivery provides relief of climacteric symptoms with a strong safety profile.
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