WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY
Cardiovascular Disorders and Probable Dementia
Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. (See
CLINICAL STUDIES
and
WARNINGS, Cardiovascular disorders
and
Probable dementia.)
The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis, pulmonary embolism, stroke and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. (See
CLINICAL STUDIES
and
WARNINGS, Cardiovascular disorders.)
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See
CLINICAL STUDIES
and
WARNINGS, Probable dementia
and
PRECAUTIONS, Geriatric Use.)
Breast Cancer
The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer. (See
CLINICAL STUDIES
and
WARNINGS, Malignant neoplasms,
Breast Cancer
.)
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins.
Progestins with estrogens 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 contain micronized progesterone for oral administration.
PROMETRIUM Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized 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)
A randomised controlled double-blind clinical trial of 17-hydroxyprogesterone
caproate for the prevention of preterm birth in twin gestation (PROGESTWIN):
evidence for reduced neonatal morbidity. [2015]
POPULATION: Unselected women with twin pregnancies... CONCLUSIONS: Intramuscular 17OHPC therapy did not reduce PTB before 37 weeks of
Elagolix, an oral GnRH antagonist, versus subcutaneous depot medroxyprogesterone
acetate for the treatment of endometriosis: effects on bone mineral density. [2014]
This randomized double-blind study, with 24-week treatment and 24-week
posttreatment periods, evaluated the effects of elagolix (150 mg every day, 75 mg
twice a day) versus subcutaneous depot medroxyprogesterone acetate (DMPA-SC) on
bone mineral density (BMD), in women with endometriosis-associated pain (n =
252)...
Maintenance tocolysis with oral micronized progesterone for prevention of preterm
birth after arrested preterm labor. [2014]
labor... CONCLUSION: Maintenance tocolysis with OMP significantly prolonged pregnancy and
Evaluation of sex, race, body mass index and pre-vaccination serum progesterone
levels and post-vaccination serum anti-anthrax protective immunoglobulin G on
injection site adverse events following anthrax vaccine adsorbed (AVA) in the CDC
AVA human clinical trial. [2014]
site AEs... CONCLUSIONS: Female and non-black participants had a higher proportion of AVA
A four week randomised control trial of adjunctive medroxyprogesterone and
tamoxifen in women with mania. [2014]
Emerging research has suggested that hormone treatments such as selective
oestrogen receptor modulators (SERMs) or progestins may be useful in the
treatment of mania. The current pilot study compared the use of the SERM
tamoxifen and the progestin medroxyprogesterone acetate (MPA), as an adjunct to
mood stabiliser medications, for the treatment of mania symptoms in 51 women in a
28-day double blind, placebo controlled study...
Clinical Trials Related to Prometrium (Progesterone)
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.
Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization (IVF) [Completed]
The goal of this research study is to compare the pregnancy rates for two different types of
progesterone supplementation after in-vitro fertilization (IVF).
Vaginal Compared to Intramuscular Progesterone for Frozen Embryo Transfer [Not yet recruiting]
Comparing IM vs. Vaginal Progesterone for Pre-term Birth [Completed]
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.
Progesterone and Brain Imaging Study [Recruiting]
The purpose of this study is to learn whether a sex hormone called progesterone is helpful
in reducing cigarette smoking and craving for cigarettes. This study also includes brain
imaging to measure possible effects of progesterone on certain neurochemicals. These
neurochemicals are called gamma-aminobutyric acid (or GABA for short) and glutamate. Both
nicotine and progesterone affect these brain chemicals.
Individuals wishing to participate in this study must be medically healthy men or women who
smoke at least 10 cigarettes per day or greater. Participants must not suffer from a mental
illness or use drugs other than nicotine. Participants cannot have any implanted metallic
devices such as pacemakers, orthodontic braces, or shrapnel. Participants must not have
peanut allergies and must never have had a reaction to progesterone. Finally, participants
cannot be taking any medications for anxiety, depression or insomnia.
Women: Female participants cannot have taken a hormonal contraceptive in the past six
months.
Reports of Suspected Prometrium (Progesterone) 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: 2015-08-10
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