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Prometrium (Progesterone) - Summary

 
 



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.

 

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.


See all Prometrium indications & dosage >>

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...

more studies >>

Clinical Trials Related to Prometrium (Progesterone)

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.

Vaginal Progesterone as a Treatment for Women Active Preterm Labor [Recruiting]
The purpose of this study is to compare how well vaginal progesterone works delaying the time to delivery in women with preterm labor compared to placebo. The study will also compare the effect of vaginal progesterone on neonatal outcomes, rate of spontaneous preterm delivery, cervical length and biomarkers of preterm delivery in women diagnosed with and treated with medication to stop preterm labor.

more trials >>

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 >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based 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

 

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.

 

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.

See all Prometrium reviews / ratings >>

Page last updated: 2015-08-10

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