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Active ingredient: Progesterone - Brands, Medical Use, Clinical Data

Brands, Medical Use, Clinical Data

Drug Category

  • Contraceptives
  • Progestins

Dosage Forms

  • Capsule
  • Gel
  • Implant
  • Liquid
  • Solution

Brands / Synonyms

Agolutin; Amen; Bio-Luton; Colprosterone; Corlutin; Corlutina; Corluvite; Corporin; Corpus Luteum Hormone; Crinone; Crinone Progesterone Gel; Curretab; Cyclogest; Cyclogesterin; Cycrin; Delalutin; Depo-Provera; Depo-Subq Provera 104; Flavolutan; Fologenon; Gesterol; Gesterol 100; Gesterol 50; Gestiron; Gestone; Gestormone; Gestron; Glanducorpin; Gynlutin; Gynoluton; Gynolutone; Hormoflaveine; Hormoluton; Hydroxyprogesterone Caproate; Lingusorbs; Lipo-Lutin; Lucorteum; Lucorteum Sol; Luteal Hormone; Luteine; Luteinique; Luteocrin Normale; Luteodyn; Luteogan; Luteohormone; Luteol; Luteopur; Luteosan; Luteostab; Luteovis; Lutex; Lutidon; Lutin; Lutociclina; Lutocuclin M; Lutocyclin; Lutocyclin M; Lutocylin; Lutocylol; Lutoform; Lutogyl; Lutren; Lutromone; Medroxyprogesterone Acetate; Membrettes; Methylpregnone; MPA; Nalutron; Percutacrine; Percutacrine Luteinique; Piaponon; Pranone; Pregnenedione; Prempro/Premphase; Primolut; Prochieve; Progekan; Progestasert; Progesterol; Progesterona [Inn-Spanish]; Progesterone; Progesterone [Ban:Inn:Jan]; Progesterone [Progestins]; Progesteronum; Progesteronum [Inn-Latin]; Progestin; Progestogel; Progestol; Progeston; Progestone; Progestosol; Progestron; Progestronol; Projestaject; Prolets; Prolidon; Prolutin; Proluton; Prolutone; Prometrium; Protormone; Provera; Syngesterone; Syngestrets; Synovex S; Syntolutan; Thiuram E; Thiuranide; Utrogestan

Indications

For progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency and for the treatment of secondary amenorrhea. Also used as a female contraceptive.

Pharmacology

Progesterone is a progestin or a synthetic form of the naturally occurring female sex hormone, progesterone. In a woman's normal menstrual cycle, an egg matures and is released from the ovaries (ovulation). The ovary then produces progesterone, preventing the release of further eggs and priming the lining of the womb for a possible pregnancy. If pregnancy occurs, progesterone levels in the body remain high, maintaining the womb lining. If pregnancy does not occur, progesterone levels in the body fall, resulting in a menstrual period. Progesterone tricks the body processes into thinking that ovulation has already occurred, by maintaining high levels of the synthetic progesterone. This prevents the release of eggs from the ovaries.

Mechanism of Action

Binds to the progesterone and estrogen receptors. Target cells include the female reproductive tract, the mammary gland, the hypothalamus, and the pituitary. Once bound to the receptor, progestins like Progesterone will slow the frequency of release of gonadotropin releasing hormone (GnRH) from the hypothalamus and blunt the pre-ovulatory LH (luteinizing hormone) surge.

Absorption

Progesterone absorption is prolonged with an absorption half-life of approximately 25-50 hours.

Toxicity

Not Available

Biotrnasformation / Drug Metabolism

Progesterone is metabolized primarily by the liver largely to pregnanediols and pregnanolones.

Contraindications

PROMETRIUM Capsules should not be used in women with any of the following conditions:

1. PROMETRIUM Capsules should not be used in patients with known hypersensitivity to its ingredients. PROMETRIUM Capsules contain peanut oil and should never be used by patients allergic to peanuts.
2. Undiagnosed abnormal genital bleeding.
3. Known, suspected, or history of cancer of the breast.
4. Active deep vein thrombosis, pulmonary embolism or history of these conditions.
5. Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction).
6. Liver dysfunction or disease.
7. Known or suspected pregnancy. There is no indication for PROMETRIUM Capsules in
pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy.

Drug Interactions

Drug/Laboratory Test Interactions

The following laboratory results may be altered by the use of estrogen-progestin combination drugs:

  • Increased sulfobromophthalein retention and other hepatic function tests.
  • Coagulation tests: increase in prothrombin factors VII, VIII, IX and X.
  • Metyrapone test.
  • Pregnanediol determination.
  • Thyroid function: increase in PBI, and butanol extractable protein bound iodine and decrease in T3 uptake values.

Fasting and 2-hour plasma insulin and glucose levels following an oral glucose tolerance test (OGTT) and figrinogen levels were measured in patients receiving PROMETRIUM® Capsules at a dose of 200 mg/day for 12 days per 28 day cycle in combination with conjugated estrogens 0.625 mg/day (n-120). Table 6 summarizes this data. Plasma insulin levels 2 hours post-OGTT were decreased from baseline. The fasting plasma glucose and fasting plasma insulin levels were also decreased from baseline. Glucose levels 2 hours post-OGTT were increased slightly. There was no effect on fibrinogen levels.

For information on changes in lipid profile, see the CLINICAL PHARMACOLOGY, Clinical Studies subsection, Table 5.

Table 6

Mean Changes from Baseline in Insulin and Glucose Levels After 36 Months of Treatment

Parameter
Treatment Group Mean
(Mean % Change)

Conjugated Estrogens 0.625 mg + PROMETRIUM 200mg (cyclical)a

Conjugated Estrogens 0. 625 mg (only)

Placebo

N= 173 to 176b N=170 to 172b N=171

mean

mean % change

mean

mean % change

mean

mean % change

OGTT Insulin
(pmol/L)
Fasting
2 hour
-2.2
-45.2
-6.2
 -14.5
-1.1
 -23.9
-3.2
 -7.9
5.1
 -29.7
14.2
 -9.1
Glucose(mg/dL)
 Fasting
2 hour
-3.0
 3.6
-2.9
 5.2
-2.7
5.0
-2.7
7.8
-1.0
2.1
-0.9
3.9

a There are no significant changes (p<0.05) from conjugated estrogens values
b Number of subjects (N) varies by parameter

Also see CLINICAL PHARMACOLOGY.

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