Progesterone Even Release Tablets (ERT)

Have you considered Progesterone oral even-release tablet (ERT) for your hormone patients?

Here’s what you need to know:

  1. Capsules are not your only option for oral progesterone therapy! Micronized progesterone can be taken orally in capsule or tablet form.
  2. Our pharmacy introduced the ERT, a breakthrough progesterone delivery system which is exclusively from Pharmacy Solutions.
  3. While the capsule is an immediate release form, oral tablets are an even-release form and can be taken only once or twice a day. This helps to produce consistent levels of the progesterone in the blood throughout the day.
  4. The consistent progesterone blood levels produced by ERT help better manage the symptoms of PMS or menopause and avoid daytime drowsiness, erratic menstrual cycles or breakthrough bleeding.
  5. Oral Even-Release Tablet Dosing Options: 100 mg, 200 mg, 300 mg, 400 mg
  6. Scored to allow patients to easily take half a tablet.
Progesterone Even Release Tablets

Progesterone Imbalance and Therapy

The balance of progesterone and estrogen in a woman’s body is extremely important. An imbalance in these hormones can result in symptoms of PMS, perimenopause, or menopause causing symptoms including mood swings, anxiety, cravings for sweets, depression, weight gain, bloating, and breast tenderness. Progesterone therapy is essential for menopausal women with an intact uterus who are using estrogen therapy. If taken alone, estrogen can cause the cells in the uterine lining to become crowded or malformed. Progesterone opposes that effect, protecting against endometrial abnormalities.

A Pharmacokinetic Study of Micronized Natural Progesterone Extended-Release Tablets

Eileen P. Kirk, MD, Suzanne Serat, CNM, Lara J. Burrows, MD, Leila A. Mott, MS, Kiang-Teck J. Yeo, PhD, Thomas Fitzmaurice, PhD, Lionel D. Lewis, MB.BCh, MD

Department of Obstetrics and Gynecology, Section of Biostatistics and Epidemiology, Departments of Pathology, Medicine, Pharmacology and Toxicology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

Objective:

To define the pharmacokinetic parameters of extended release micronized natural progesterone following daily dosing over two weeks in healthy postmenopausal women.

Methods:

Twenty-four postmenopausal women were randomized to receive either placebo, 100, 200, or 300 mg tablets of extended release micronized natural progesterone daily for two weeks. Multiple blood samples were analyzed for serum progesterone concentrations. Pharmacokinetic parameters: maximum serum concentration (Cmax), half-life (t1/2), and area under the curve (AUC) were calculated by non-compartmental analysis.

Results:

The median time to reach maximum, serum progesterone concentration was approximately three hours for all doses on both the first and last day of treatment. Steady state concentrations were reached by the fourth day. The maximum serum progesterone concentrations (mean Cmax) on the last day of the study were 2.9 (+ 1.9) ng/ml, 5.2 (+ 5.0) ng/ml, and 13.5 (+ 15) ng/ml for the 100, 200, and 300 mg dose and placebo however, no statistically significant difference among the three doses for AUC, half-life, or Cmax.

Given these mean Cmax values, a sample size of 11 in each group would be needed to detect a significant difference in the means with 80% power.

Conclusions:

Pharmacokinetic parameters of extended release micronized natural progesterone were defined. Extended release natural progesterone produced serum concentrations of progesterone in the luteal phase range. The average elimination half-life of the 300mg preparation was 18 hours supporting once daily dosing.

Extended release micronized natural progesterone was well tolerated. (1998)

Important Points to Remember

  • Progesterone is the hormone with a naturally calming effect. Oral forms of natural progesterone may cause drowsiness or dizziness, especially in an immediate release form.
  • When choosing the appropriate dosage, it is important to consider: absorption characteristics, symptom control, side effects, ease of administration, and expense.
  • We're here to help with your questions. Call our clinical pharmacy team and we will work with you to help select the dosage form that will most effectively manage your patient’s symptoms and suit their lifestyle.
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