Women in Balance

Progesterone & Menopausal Symptoms

Relief of Menopausal Symptoms

Fitzpatrick LA, Pace C, Wiita B. Comparison of regimens containing oral micronized progesterone or medroxyprogesterone acetate on quality of life in postmenopausal women: a cross-sectional survey. J Women Health Gend Based Med 2000 May;9(4):381-7.

A cross-sectional survey was conducted to examine quality of life (QOL) related to physiological, somatic, and vasomotor effects of switching progestogen treatment from medroxyprogesterone acetate (MPA) to micronized progesterone in postmenopausal women already using hormone replacement therapy (HRT). One hundred seventy-six women who were currently using hormone replacement therapy (HRT) containing micronized progesterone for 1-6 months and had previously received HRT containing MPA were surveyed to assess QOL. Women using micronized progesterone-containing HRT experienced significant improvement in vasomotor symptoms, anxiety, somatic complaints and depressive symptoms. Women reported improved control of menopausal symptoms and perceptions of their vaginal bleeding patterns while on the micronized progesterone-containing regimen. Approximately 80% of women reported satisfaction with the progesterone-containing therapy. A micronized progesterone-containing HRT therapy offers the potential for improved QOL with respect to menopausal symptoms.
Leonetti HB, Longo S, Anasti JN. Transdermal progesterone cream for vasomotor symptoms and postmenopausal bone loss. Obstet Gynecol 1999 Aug;94(2):225-8.

In this randomized controlled trial, 102 menopausal women were treated with topical progesterone (Pro-Gest Ò , 20 mg daily) or placebo and monitored for 1 year. Improvement in vasomotor symptoms was seen in 83% of the women in the treatment group who had experienced hot flashes, compared to 19% in the placebo group (p< .001). There was no difference noted in bone mineral densities between groups after one year. All women studied received a daily multivitamin and 1200 mg calcium.
Stephenson, Kenna; Price, Carol; Kurdowska, Anna; Neuenschwander, John; Stephenson, John; Pinson, Barbara; Stephenson, Douglas; Alfred, Denita; Krupa, Agnieszka; Mahoney, Debra; Zava, David; Bevan, Mary.enna Stephenson, Carol Price, Anna Kurdowska, Pierre Neuenschwander, John Stephenson, Barbara Pinson, Douglas Stephenson, Denita Alfred, Agnieszka Krupa, Debra Mahoney, David Zava, Mary Bevan.
"Topical Progesterone Cream Does Not Increase Thrombotic and Inflammatory Factors in Postmenopausal Women. Session Type: Publication Only" Blood, Volume 104, issue 11, November 16, 2004. Women's Wellness Center, University of Texas Health Center at Tyler, Tyler, TX, USA; College of Nursing and Health Sciences, University of Texas at Tyler, Tyler, TX, USA; Dept. of Biochemistry, University of Texas Health Center at Tyler, Tyler, TX, USA; Stephenson's Pharmacy, Tyler, TX, USA; Occupational Medicine, University of Texas Health Center at Tyler, Tyler, TX, USA; Dept. of Medicine, University of Texas Health Center at Tyler, Tyler, TX, USA; ZRT Laboratories, Beaverton, OR, USA; College of Business, University of Texas at Tyler, Tyler, TX, USA

Postmenopausal women have an increased risk of cardiovascular disease, and heart disease is the leading cause of death in postmenopausal American women. Conventional hormone replacement therapy has been shown to result in an increase in thrombotic events in large prospective clinical trials including HERS I, and the recently halted Women's Health Initiative.

One possible mechanism for this observed increase is the unfavorable net effects of conjugated equine estrogens and medroxyprogesterone acetate on the hemostatic balance and inflammatory factors. An estimated 50 million American women are peri or postmenopausal and clinical therapies for menopausal symptoms remain a significant challenge in light of the known thrombotic risks.

In this prospective blinded study, we examined the short-term effect of topical progesterone cream on menopausal symptom relief in 30 healthy postmenopausal women. Potential adverse effects of topical progesterone on hemostatic and inflammatory factors and cortisol levels were also examined. Subjects were randomized to first receive either 20 mg of topical progesterone cream or placebo cream for 4 weeks.

Following a subsequent 4-week washout period, subjects were crossed over to either placebo cream or active drug for an additional 4-week period. In each case, progesterone and cortisol levels were monitored by salivary sampling. Baseline values, 4-week follow-up values and end-of-study values were also obtained for the Greene Climacteric Scale, total factor VII:C, factor VIIa, factor V, fibrinogen, antithrombin, PAI-1, CRP, TNFá, and IL-6.

For subjects receiving 20 mg of topical progesterone cream for 4 weeks, Greene Climacteric Scale scores were consistently and significantly improved (decreased) over baseline, demonstrating significant relief from menopausal symptoms.

In addition, in a subpopulation of hypercortisolemic women, topical progesterone was associated with a favorable decrease in nocturnal cortisol. Surprisingly, and in sharp contrast to earlier studies with conventional hormone replacement therapy, topical progesterone had no effect on any of the hemostatic components examined: total factor VII:C, factor VIIa, factor V, fibrinogen, antithrombin, and PAI-1 levels were all unchanged. Levels of CRP, TNFá and IL-6 also remained unchanged.

From this study we conclude that administration of topical progesterone cream at a daily dose of 20 mg significantly relieves menopausal symptoms in postmenopausal women without adversely altering prothrombotic potential. Since the thrombotic complications that are typically observed with conventional hormone replacement therapy do not seem to occur with topical progesterone, this treatment should be seriously considered as an effective and safe alternative clinical therapy for women suffering from menopausal symptoms.
Wetzel W. Micronized progesterone: a new option for women's health care. Nurse Pract 1999 May;24(5):62-6, 71, 75-6.

This paper discusses the use of micronized progesterone as a safe, effective, and well-tolerated therapy and reviews indications for use. It also includes case studies and issues of patient compliance and the need for an individualized treatment plan for women receiving hormone therapy.

Sleep
Montplaisir J, Lorrain J, Denesle R, Petit D. Sleep in menopause: differential effects of two forms of hormone replacement therapy. Menopause 2001; 8(1):10-16.

This randomized clinical trial compared the effects of conjugated equine estrogen (CEE) and medroxyprogesterone acetate to CEE and oral micronized progesterone. Twenty-one postmenopausal women were studied in a sleep lab, with results demonstrating an improvement in subjective measures of menopausal symptoms and sleep in both groups. The group receiving natural progesterone had significantly improved sleep efficiency, whereas the medroxyprogesterone acetate group did not, suggesting that the former might better improve sleep in postmenopausal women.

Quality of Life
Ryan N, Rosner A. Quality of life (QOL) and costs associated with micronized progesterone and medroxyprogesterone acetate in hormone replacement therapy for non-hysterectomized, postmenopausal women. Clin Ther 2001 Jul;23(7):1099-115.

This prospective, multicenter, randomized, parallel-group study enrolled 182 postmenopausal women 45 to 65 years of age and evaluated the quality of life and menopausal symptoms associated with the use of medroxyprogesterone acetate vs oral micronized progesterone when used as a part of a regular hormone replacement therapy. Menopausal symptoms improved in both groups from baseline to 9 months, as did QOL measures. In addition, patients using micronized progesterone had specific improvements in the areas of cognition and menstrual problems whereas the patients using MPA did not. Micronized progesterone was seen as an effective, cost-comparable alternative to MPA as well as being better tolerated.
Sherwin BB. Progestogens used in menopause. Side effects, mood and quality of life. J Reprod Med 1999 Feb;44(2 Suppl):227-32.

This review summarizes the effects of progesterone on mood and other brain functions. Progesterone receptors are present in many of the same areas of the brain as estrogen receptors, including the limbic system and hypothalamus. The limbic system plays a prominent role in regulating mood and emotion. As a comparison, progesterone decreases brain excitability, while estrogens increase it. This relates to why women with epilepsy have a higher frequency of seizures during the part of the cycle when estrogen levels are high, and a reduced frequency when progesterone levels are high. Estrogen and progesterone may also have differing effects on MAO, thereby affecting concentration of serotonin (a mood elevator) in the brain.

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