Long-Term Effects of Topical Progesterone Cream Application
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A Case Study

Article by Elias F. Ilyia, Ph.D., Deborah McLure, B.Sc., and Michel Y. Farhat, Ph.D

Abstract: Key words: Progesterone cream, female hormone profile, salivary hormone testing, hormone free fraction, hormone overdose.

It has been observed that the premenstrual tension, bloating as well as mood swings and depression, experienced by perimenopausal women can be relieved by exogenous progesterone administration, as part of a well-balanced hormone replacement regimen. Natural progesterone is derived from plants, is isomolecular to human progesterone and is available to women in over-the-counter gels and creams. The pharmacodynamics of transdermal creams are unknown, and thus self-medication may lead to overuse and overdose as well as exacerbation of the symptoms. We describe the case of a forty five year-old woman showing excessive elevations in salivary progesterone, following use of low pharmacological concentrations of progesterone cream. The elevated progesterone levels were maintained for months after cessation of cream use. Salivary testing, a measure of the free fraction of the hormone, is used to assess the patient hormonal profile. This report illustrates the problem of overdosing with topical application of progesterone creams and the long-term side effects associated with it.

Case Report 1

A 52-year-old perimenopausal woman was prescribed cyclical progesterone augmentation to alleviate her postmenopause-like symptoms. She had been on 1/8th of a teaspoon of a transdermal 5% progesterone (P1) cream twice a day (between days 4 and 20 of a 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 to 3 days thereafter, and salivary estradiol and progesterone levels were determined by an enzyme-linked immunosorbent assay (ELISA) (Tallon etal.,1984). The patient hormone profile showed significantly elevated P1 levels (>1000 pg/mL) between days 5 and 25 (normal salivary P1 range is <500 pg/mL). P1 levels remained abnormally high even when the progesterone was not being used as seen on day 2 (reflecting residual effect from the previous cycle) and day 24 (showing carryover from the present cycle) (Fig.1A).

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% P1 cream, twice a day. As in the previous case, her hormone profile revealed significantly exaggerated salivary P1 levels (<1000 pg/mL) throughout the collection period (Fig.1B).

(Figures 1A and 1B shown on following page- to be added)

TABLE
Fig.1. Female hormone panel showing salivary estradiol and progesterone levels (pg/mL) at different time points throughout the menstrual cycle of two female patients reported in Case 1(A) and Case 2 (B).

References

1.xxDarj E, Axelsson O, Carlstrom K, Nilsson S, Von Schoultz B. Liver metabolism during treatment with estradiol and natural progesterone.
Gynecol Endocrinol 1993; 7:111-4.

2.xxDonaldson AS, Jeffcoate L, Suffi SB. Assays of oestradiol and progesterone in saliva in thexassessment of ovarian function. Front Oral
Physiol 1984; 5:80-86.

3.xxTallon DF, Gosling JP, Buckley PM, Dooley MM, Cleere WF, O'Dwyer Em,
Fottrell PF. Directxsolid-phase enzyme immunoassay of progesterone in
saliva. Clin Chem 1984; 30:1507-1511.

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