Variability in BHRT Study Results

We regularly review the medical literature to most effectively meet the needs of our patients. Recently, there has been a paucity of information on compounded medications, and many of the studies which are published have failed to address key points which are pertinent when evaluating hormone replacement therapy:

  • When topical preparations are used, most studies fail to mention the base. Selection of the right base is key to the success of any medication. While a PLO gel may be good for some topical medications, liposomal gels, cosmetic cream bases or specialized HRT bases may be more appropriate for other medications or hormones.
  • Studies may report that one dosage form or route of administration is superior to another, without measuring hormone levels using a method that is appropriate for that route of administration (such as saliva or blood spot testing when hormones are administered topically). 

  • Perhaps the dose needs to be adjusted to provide the body with the same amount of hormones by a different route, which may have inherent advantages (such as topical therapy, which is not subject to first pass hepatic metabolism).

If you have read studies that raise questions or concerns, please contact our compounding pharmacist to discuss.

Treatment of Postmenopausal Women with Topical Progesterone Creams and Gels

Despite low serum levels following the use of topical progesterone creams and gels, salivary and capillary blood levels are very high and a protective endometrium has been reported in a limited number of studies. According to Frank Stanczyk, PhD, of University of Southern California Keck School of Medicine, long-term studies with topical progesterone creams and gels are likely to provide valuable information for treatment of postmenopausal women.

Climacteric. 2014 Dec;17 Suppl 2:8-11.

Progesterone Levels in Serum, Whole Blood, Saliva, and Capillary Blood

David Zava, PhD of ZRT Laboratory, Beaverton, OR, Frank Stanczyk, PhD et al. conducted a study to investigate the distribution of progesterone in venous whole blood, venous serum, fingertip capillary blood, and saliva after its topical application in both cream and gel formulations.

Postmenopausal women were randomized to receive 80 mg of progesterone cream or gel applied daily for 14 days, crossing over after a 14-day washout. On the last day of each treatment period, venous blood, fingertip capillary blood, and saliva were sampled frequently for 24 hours after the final application.

After progesterone cream or gel application, serum progesterone levels rose gradually, reaching a peak at 9 and 8 hours, respectively. Whole venous blood levels followed a pattern similar to that of serum but were considerably lower. Saliva progesterone showed a peak at 1 and 6 hours after cream and gel application, respectively, and Cmax (maximum drug concentration) was comparable with cream and gel. Saliva AUC (Area Under the Curve, which is directly proportional to the total amount of unchanged drug that reaches systemic circulation) was substantially higher than the
corresponding AUC for serum or whole blood. In capillary blood, the AUC was also similar with both cream and gel formulations but was dramatically higher than the corresponding areas under the curve for venous serum and whole blood.

In conclusion, after application of topical progesterone, saliva and capillary blood levels are approximately 10-fold and 100-fold greater, respectively, than those seen in serum or whole blood. High capillary blood and saliva levels indicate high absorption and transport of progesterone to tissues. Reliance on serum levels of progesterone for monitoring topical dose could lead to underestimation of tissue levels and consequent overdose.

Menopause. 2013 Nov;20(11):1169-75.

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