WARNING
Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia. (See
WARNINGS, Cardiovascular disorders
and
Dementia.)
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
and
WARNINGS, Cardiovascular disorders
and
Malignant neoplasms,
Breast cancer
.)
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, WARNINGS, Dementia
and
PRECAUTIONS, Geriatric Use.)
Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. 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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FEMHRT SUMMARY
femhrt ® (norethindrone acetate/ethinyl estradiol tablets) is a continuous dosage regimen of a progestin-estrogen combination for oral administration. The following two strengths of femhrt tablets are available: femhrt (0.5 mg/2.5 mcg): Each white oval tablet contains 0.5 mg norethindrone acetate and 2.5 mcg ethinyl estradiol. femhrt (1 mg/5 mcg): Each white D-shaped tablet contains 1 mg norethindrone acetate and 5 mcg ethinyl estradiol.
femhrt is indicated in women with an intact uterus for the:
- Treatment of moderate to severe vasomotor symptoms associated with the menopause.
- Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis. Non-estrogen medications should be carefully considered.
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
Risk factors for osteoporosis include low bone mineral density, low estrogen levels, family history of osteoporosis, previous fracture, small frame (low BMI), light skin color, smoking, and alcohol intake. Response to therapy can be predicted by pre-treatment serum estradiol, and can be assessed during treatment by measuring biochemical markers of bone formation/resorption, and/or bone mineral density.
Estrogen therapy reduces bone resorption and retards or halts postmenopausal bone loss. Studies have shown a risk ratio of about 0.4 for hip and wrist fractures in women whose estrogen therapy was begun within a few years of menopause, compared to women taking calcium and vitamin D alone. Studies also suggest that estrogen reduces the rate of vertebral fractures. Even when started as late as 6 years after menopause, estrogen reduces further loss of bone mass for as long as treatment is continued. When estrogen therapy is discontinued, bone mass declines at a rate comparable to the immediate postmenopausal period.
Data from the Women's Health Initiative study showed that use of estrogen-plus-progestin (dose equivalent to 0.625 mg CE and 2.5 mg MPA) resulted in about 5 less hip fractures per 10,000 women-years, compared to use of placebo (risk ratio about 0.66).
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NEWS HIGHLIGHTSMedia Articles Related to Femhrt (Norethindrone / Ethinyl Estradiol)
Millions Still Lack Access to Modern Contraception, Study Says
Source: MedicineNet Birth Control Specialty [2013.03.12]
Title: Millions Still Lack Access to Modern Contraception, Study Says
Category: Health News
Created: 3/11/2013 8:36:00 PM
Last Editorial Review: 3/12/2013 12:00:00 AM
Give Teens Access to Emergency Contraception, Pediatricians Say
Source: MedicineNet Miscarriage Specialty [2012.11.26]
Title: Give Teens Access to Emergency Contraception, Pediatricians Say
Category: Health News
Created: 11/26/2012 10:35:00 AM
Last Editorial Review: 11/26/2012 12:00:00 AM
Copper IUD Does Not Increase Period Pain
Source: Sexual Health / STDs News From Medical News Today [2013.05.10]
Previous scientific studies have suggested that women who use a copper IUD for contraception suffer from worse period pain, but a study at the Sahlgrenska Academy, University of Gothenburg, that followed 2,100 women over a 30-year period shows that this is not the case...
Clinical Trials Related to Femhrt (Norethindrone / Ethinyl Estradiol)
A Study in Healthy Female Participants Investigating the Effect of TMC435 on the Pharmacokinetics of the Synthetic Hormones of the Oral Contraceptive Ovysmen [Recruiting]
The purpose of this study is to investigate the effect of steady-state concentrations of
TMC435 (administered once a day) on the steady-state pharmacokinetics of ethinylestradiol
and norethindrone (administered once a day) and on the levels of progesterone, luteinizing
hormone and follicle-stimulating hormone, in healthy female participants. Ethinlyestradiol
and norethindrone are synthetic hormones, which constitute the oral contraceptive Ovysmen.
Also the short-term safety and tolerability of the co-administration of TMC435 and Ovysmen
will be studied. Steady-state is a term that means that the drug has been given long enough
so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is
being investigated for the treatment of chronic hepatitis C virus (HCV) infection.
Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in
the body and eliminated from the body. A contraceptive is a method that prevents pregnancy.
Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation [Recruiting]
The purpose of this research study is to gain a better understanding of the changes that may
occur in the breast when a woman uses an oral contraceptive (birth control pill). Some
research indicates that women who use birth control pills with lower amounts of estrogen (a
hormone in the birth control pill) may have lower breast cell growth than women who use
birth control pills with a higher amount of estrogen; this research will examine that in
detail. This research will also test whether the results found in HS-07-00269 can be
confirmed.
Randomized Trial of Induction Therapies in High Immunological Risk Kidney Transplant Recipients [Recruiting]
The purpose of this research study is to find out the effects of adding B lymphocyte
modulating agents in patients at risk for rejection receiving an anti-rejection
(immunosuppressive) regimen of Thymoglobulin® induction with Prograf®, Cellcept® and
corticosteroid therapy.
Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women [Recruiting]
The goal of this three-armed randomized controlled trial is to establish the relative roles
of treatment of hyperandrogenism versus obesity (as the largest modifiable factor
contributing to insulin resistance) in treating infertility and improving pregnancy outcomes
among obese PCOS women. The investigators hypothesize that the key to restoring ovulation
leading to live birth is to correct hyperandrogenism with oral contraceptive pills, but the
key to avoiding later pregnancy complications is to improve insulin sensitivity with weight
loss.
Optimizing Ovulation Induction in the Poor Responder [Not yet recruiting]
The purpose of this randomized controlled trial is to compare the efficacy and effect of
luteal estradiol and combined oral contraceptive pills (COPC) on follicle recruitment and
synchrony in a poor responder population. The randomized groups consist of: 1. patients
receiving luteal estradiol prior to ovulation induction; and 2. patients receiving COCPs for
1 month prior to ovulation induction. Follicle characteristics and serum biomarkers will be
followed and compared in each group. Coefficient of variation will be used to evaluate
follicle size discrepancy. Chi square analysis will be used to compare categorical variables
between treatment groups. Both estradiol and COPCs are used clinically in assisted
reproduction, so this study affords no additional risks to the participants.
Reports of Suspected Femhrt (Norethindrone / Ethinyl Estradiol) Side Effects
Hypertension (5),
Contusion (3),
Fall (3),
Femur Fracture (2),
Drug Interaction (2),
Cyst (2),
Limb Crushing Injury (2),
Speech Disorder (2),
Balance Disorder (2),
Palpitations (2), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Femhrt has an overall score of 7.50. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Femhrt review by 58 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | menopause |
| Dosage & duration: | | .5 mg taken once daily for the period of 5 years |
| Other conditions: | | osteopenia |
| Other drugs taken: | | fosomex | | |
Reported Results |
| Benefits: | | I have been taking this treatment for 4 years and the goal is to prevent any more bone loss and possibly to improve it. Combined with weight bearing exercise supposedly my bone loss will change. I had a test a year after I started taking fosamex and there was slight improvement; I have not had another test since. I will be due for a test my next annual obg visit. |
| Side effects: | | none |
| Comments: | | once a week with water no food,drink or reclining for 30 minutes |
|
| | Femhrt review by 49 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | menopause |
| Dosage & duration: | | 1 mg/5mcg taken 1x daily for the period of 2 mos. |
| Other conditions: | | hypothyroid disease |
| Other drugs taken: | | synthryoid | | |
Reported Results |
| Benefits: | | reduced hot flashes; reduced heart palpitations |
| Side effects: | | mood swings; not enough estrogen |
| Comments: | | I started taking the drug 2 months ago to streamline a regime that consisted of taking estrodial and a progestrene cream. So far, I feel it doesn't have enough estrogen to regulate mood swings and dryness of skin. I also have breast tenderness and continued heart palpitations. I think I prefer going back to activella along with the progestrone cream. |
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Page last updated: 2013-05-10
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