WARNINGS
Progestins and estrogens should not be used for the prevention of cardiovascular disease. (See WARNINGS, Cardiovascular Disorders.)
The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
Other doses of oral conjugated estrogens with medroxyprogesterone and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials. In the absence of comparable data and product-specific studies, the relevance of the WHI findings to other products has not been established. Therefore, the risks should be assumed to be similar for all estrogen and progestin products. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
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PROMETRIUM SUMMARY
PROMETRIUM®
(progesterone, USP)
Capsules 100 mg
Capsules 200 mg
PROMETRIUM® (progesterone, USP) Capsules contain micronized progesterone for oral administration.
PROMETRIUM Capsules are indicated for use in the prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.
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NEWS HIGHLIGHTS
Published Studies Related to Prometrium (Progesterone Oral)
Progesterone for premenstrual syndrome. [2012]
CONCLUSIONS: The trials did not show that progesterone is an effective
Physiological doses of progesterone potentiate the effects of triazolam in healthy, premenopausal women. [2011.06]
RATIONALE: Gender plays a critical role in the effects of drugs and drug abuse liability. Biological factors, including ovarian hormones, may contribute to gender differences in drug abuse. Preclinical and some clinical research suggests that progesterone and its metabolites have activity at the GABA(A) receptor and may enhance the effect of GABAergic compounds (e.g., benzodiazepines). Because women are exposed to varying levels of progesterone from puberty until menopause, and appear more sensitive to the negative consequences of benzodiazepine use, it is important to understand the impact of progesterone on GABAergic drug effects. OBJECTIVES: The purpose of this experiment was to characterize the behavioral effects of progesterone, alone and in combination with the short-acting benzodiazepine, triazolam, to determine if progesterone potentiates the behavioral effects of triazolam... CONCLUSIONS: Progesterone potentiates the behavioral effects of benzodiazepines and may contribute to benzodiazepine use and abuse among women.
A randomized trial of micronized progesterone for the prevention of recurrent preterm birth. [2011.05]
We sought to evaluate the effectiveness of daily oral micronized progesterone (MP) in preventing recurrent spontaneous preterm birth (RSPB) and whether MP increases maternal serum progesterone. We performed a pilot, single-center, randomized, double-blind, placebo-controlled trial in women with a prior preterm birth and current singleton gestation at 16 to 20 weeks ( N = 33)...
Comparison of oral dydrogestrone with progesterone gel and micronized progesterone for luteal support in 1,373 women undergoing in vitro fertilization: a randomized clinical study. [2011.05]
OBJECTIVE: To compare the efficacy of oral dydrogesterone with that of micronized vaginal P gel and micronized P capsule for luteal supplementation...
Effects of percutaneous estradiol-oral progesterone versus oral conjugated equine estrogens-medroxyprogesterone acetate on breast cell proliferation and bcl-2 protein in healthy women. [2011.03.01]
In a prospective, randomized clinical study 77 women were assigned randomly to receive sequential hormone therapy with either conventional oral conjugated equine estrogens (0.625 mg) with the addition on 14 of the 28 days of oral medroxyprogesterone acetate (5 mg) or natural E(2) gel (1.5 mg) with oral micronized P (200 mg) on 14 of the 28 days of each cycle.
Clinical Trials Related to Prometrium (Progesterone Oral)
Multi-Center, Randomized, Open-Label, Parallel Group Study of a Vaginal Micronized Progesterone Tablet (Endometrin®) Compared to Crinone 8% Vaginal Gel in Female Patients Undergoing In-Vitro Fertilization (IVF) [Completed]
This multicenter, randomized, open-label study will be performed in approximately 990 healthy
females undergoing IVF. Each study center will follow their study center standard practice
for IVF unless otherwise noted in this protocol. The study centers will be provided with the
medications for down regulation, stimulation and ovulation induction. The subjects will be
randomized to study medication on the day of oocyte retrieval or the day following and will
continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be
required to return to the clinic several times during the course of the 10 week treatment
period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.
Evaluating the Roles of Estrogen and Progesterone in Heart Metabolism [Completed]
Estrogen and progesterone are two main female sex hormones. When a woman goes through
menopause, the body's production of estrogen and progesterone significantly decreases. Recent
studies have shown that the breakdown of fatty acids in cardiac muscle is important in
maintaining a healthy heart, and that estrogen may enhance this process. Also, cardiovascular
disease (CVD) occurs more frequently in postmenopausal women than in premenopausal women.
This study will determine in postmenopausal women whether estrogen increases the heart's
ability to use fats as energy and whether progesterone decreases this effect.
Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan [Suspended]
The transfer of frozen-thawed embryos can be performed in a natural ovulatory cycle or in a
hormonally manipulated cycle with a comparable pregnancy rate of 15%-20% per ET. When a
hormonally modulated ET cycle is scheduled,an artificial endometrial preparation is carried
out using estrogen stimulation followed by a concomitant progesterone treatment. Two
progestative drugs are currently used in conventional IVF treatment, Utrogetan and
Endometrin. Although Endometrin has been be efficiently used to support the luteal phase
after embryo transfer in IVF cycles, currently, there is no study that assess its efficacy
for clinical use in frozen-thawed ET cycles. The present study aims to compare the outcome of
frozen thawed ET cycles when either Endometrin or Utrogestan are used as the progestative
substitution in an artificially prepared endometrium.
Comparing IM vs. Vaginal Progesterone for Pre-term Birth [Recruiting]
This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha
hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton
pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and
neonatal outcomes.
Our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal
progesterone administered intramuscularly versus vaginally in women with singleton pregnancy
and a history of prior preterm birth.
Uterine Electrical Activity Before and After Progesterone Treatment for Preterm Labor [Recruiting]
This study will examine the effects of various formulations of progesterone on uterine
electromyographic (EMG) activity in pregnant patients in premature labor to determine if
progesterone will suppress uterine electrical activity and which formulation may be best for
inhibition of uterine activity. Patients will be monitored prior to treatment and following
treatment (every 2 to 4 hours) with one of three different formulations of progesterone for
up to two days. Patients will continue to be observed until they deliver. Comparisons will
be for uterine EMG activity from before treatment to that following treatments at 2, 4, 8,
12 24 and 48 hours and times of delivery after treatments (hours or days following
treatments). Comparisons between mean values for EMG activity between the various treatments
at the various times will also be made.
Reports of Suspected Prometrium (Progesterone Oral) Side Effects
Vaginal Haemorrhage (11),
OFF Label USE (10),
Headache (9),
Anxiety (9),
Insomnia (8),
Abortion Spontaneous (7),
Dizziness (7),
Premature Baby (7),
Maternal Exposure During Pregnancy (7),
Foetal Exposure During Pregnancy (5), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 4 ratings/reviews, Prometrium has an overall score of 8. The effectiveness score is 8 and the side effect score is 9.50. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Prometrium review by 37 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | menopause |
| Dosage & duration: | | 100mg taken 1/day for the period of 1yr and current |
| Other conditions: | | migraines |
| Other drugs taken: | | topamax,imitrex,estridol | | |
Reported Results |
| Benefits: | | ease side effects of hot flashes, lost libido, sleeplessness, and to help bring my hormones into balance along with the estridol and testosterone |
| Side effects: | | no side effects were experienced by the patient |
| Comments: | | take prometrium at bedtime every day to help also with sleeplessness along with menopausal symptoms. and also with the testosterone gel and estridol to help balance out my hormone levels as part of my bio-identical hormone therapy |
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| | Prometrium review by 50 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | perimenopause symptoms |
| Dosage & duration: | | 100 mg taken 1/day for the period of 6 months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Decrease in panic attacks (maybe these were hot flashes ... but didn't feel "hot"). Woke up less often at night from these same panic attacks. |
| Side effects: | | Still have headaches - not clear if these are from my sinuses or a side effect, but they have been persistent. Always had problems with sleep, so am not sure if that is affected by the Prometrium. |
| Comments: | | oral medication - presumably the same substance that is found in topical "natural" progesterone cream. |
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| | Prometrium review by 50 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | perimenopause symptoms |
| Dosage & duration: | | 100 mg taken 1/day for the period of 6 months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Decrease in panic attacks (maybe these were hot flashes ... but didn't feel "hot"). Woke up less often at night from these same panic attacks. |
| Side effects: | | Still have headaches - not clear if these are from my sinuses or a side effect, but they have been persistent. Always had problems with sleep, so am not sure if that is affected by the Prometrium. |
| Comments: | | oral medication - presumably the same substance that is found in topical "natural" progesterone cream. |
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Page last updated: 2013-02-10
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