Post Menopausal Tests - Abstracts
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Abstract 8

8. Topical Progesterone cream application and overdosing. Elias Ilyia Ph.D., Deborah McLure B.S., and Micheal Farhat Ph.D., J. Altern. Compl. Med. 4:1, 1998. Case Report 1: A 52 year old perimenopause woman was prescribed cyclical progesterone augmentation to alleviate her post menopause like symptoms. She had been on 1/8 of a teaspoon of transdermal 5% progesterone cream twice a day (between days 4 and 20 of her 24 day menstrual cycle) when she was referred to our laboratory for assessment of her female hormone profile. Ten saliva samples were collected at day 2 of the cycle and every 2-3 days thereafter, and salivary Estradiol and Progesterone levels were determined by an E.L.I.S.A. assay (1). The patient hormone profile shows significantly elevated progesterone (P1 levels>1,000 pg/ml) between days 5 and 25 (normal salivary P1 range <500 pg/ml). P1 levels remained abnormally high even when the progesterone cream was not being used as seen on day 2, reflecting carryover from the previous cycle and day 24 showing carryover in the present cycle. (Figure 2- to be added)

Case Report 2: A 36 year old female had been receiving hormone replacement therapy since she had undergone total hysterectomy a few years earlier. Her treatment consisted of an estrogen patch (Estraderm, 0.1%) per day and 1/4 of a teaspoon of 5% progesterone cream, twice a day. As in the previous case, her hormone profile revealed significantly exaggerated salivary progesterone levels (>1,000 pg/ml) throughout the collection. (Figure 2- to be added) Discussion: Progesterone augmentation is prescribed to women to alleviate various somatic and emotional symptoms associated with hormonal imbalance or menopause. The transdermal delivery of hormones is generally more acceptable to women since it provides some advantages over the oral routes of administration. By bypassing the liver, transdermal delivery allows for use of lower doses of steroids for a long-lasting action and avoids some of the potential drawbacks associated with hepatic steroid metabolism. (2) The pharmacokinetics of transdermal steroid delivery, however, are not well-defined. The two cases illustrated in this report clearly demonstrate that progesterone creams even when administered in small doses caused abnormally elevated circulation free fraction levels of the hormone. Moreover, sequential measurements show that the hormone levels remain significantly elevated up to 60 days even after discontinuation of the cream. In our hands, we find that approximately 90-95% of all specimens referred to our laboratory from women using topical P1 creams, show significant salivary hormone elevation. Salivary progesterone is an accurate reflection of the free circulating plasma levels of the hormone (3). The most common set of complaints reported to our laboratory by these women include gradual water retention and gradual increase in body weight as well as breast engourgement and a mild to moderate depression that becomes clinically evident in the 6th to 9th month of dermal P1 use. In conclusion, these studies suggest that women using transdermal creams should be closely monitored for overdosage, and that perhaps the use of alternative modes of progesterone administration should be considered, until more data characterizing the pharmacokinetics of progesterone creams are available.

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