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Aygestin (Norethindrone Acetate) - Summary

 
 



AYGESTIN SUMMARY

Aygestin (norethindrone acetate tablets, USP) -- 5 mg oral tablets. Aygestin, (17-hydroxy-19-nor-17(alpha)-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindrone. It is a white, or creamy white, crystalline powder.

Aygestin is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer.


See all Aygestin indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Aygestin (Norethindrone)

Multiple Sclerosis Risk Tied to Some OCs
Source: MedPage Today Neurology [2014.09.16]
BOSTON (MedPage Today) -- Women using combined oral contraceptives containing norethindrone or levonorgestrel were substantially more likely to develop multiple sclerosis than those not on "The Pill."

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Published Studies Related to Aygestin (Norethindrone)

Effect of the bile acid sequestrant colesevelam on the pharmacokinetics of pioglitazone, repaglinide, estrogen estradiol, norethindrone, levothyroxine, and glyburide. [2010.05]
The purpose of this study was to assess effects of colesevelam on the pharmacokinetics of glyburide, levothyroxine, estrogen estradiol (EE), norethindrone (NET), pioglitazone, and repaglinide in healthy volunteers. Six drugs with a potential to interact with colesevelam were studied in open-label, randomized clinical studies.

Does hormone therapy improve age-related skin changes in postmenopausal women? A randomized, double-blind, double-dummy, placebo-controlled multicenter study assessing the effects of norethindrone acetate and ethinyl estradiol in the improvement of mild to moderate age-related skin changes in postmenopausal women. [2008.09]
BACKGROUND: In postmenopausal women, declining estrogen levels are associated with a variety of skin changes, many of which are reportedly improved by estrogen supplementation. OBJECTIVE: A study was conducted to assess the effects of continuous combined norethindrone acetate (NA) and ethinyl estradiol (EE) in the control of mild to moderate age-related skin changes in postmenopausal women... CONCLUSION: Low-dose hormone therapy for 48 weeks in postmenopausal women did not significantly alter mild to moderate age-related facial skin changes.

Combined continuous ethinyl estradiol/norethindrone acetate does not improve forearm blood flow in postmenopausal women at risk for cardiovascular events: a pilot study. [2007.09]
OBJECTIVE: This study sought to determine whether combined continuous ethinyl estradiol and norethindrone acetate, a postmenopausal hormone therapy (HT) combination designed to have fewer side effects than cyclical therapies and therapies using medroxyprogesterone acetate (MPA), could improve vascular endothelial function in postmenopausal women with risk factors for cardiovascular disease (CVD)... CONCLUSIONS: In this older postmenopausal population with at least one cardiovascular risk factor, treatment with combined continuous ethinyl estradiol and norethindrone acetate failed to improve vascular endothelial function. The agent's proinflammatory effect or subclinical atherosclerosis in this population may have contributed to this finding.

Impact of combined estradiol and norethindrone therapy on visuospatial working memory assessed by functional magnetic resonance imaging. [2006.11]
CONTEXT: Hormones regulate neuronal function in brain regions critical to cognition; however, the cognitive effects of postmenopausal hormone therapy are controversial. OBJECTIVE: The goal was to evaluate the effect of postmenopausal hormone therapy on neural circuitry involved in spatial working memory... CONCLUSIONS: Hormone therapy was associated with more effective activation of a brain region critical in primary visual working memory tasks. The data suggest a functional plasticity of memory systems in older women that can be altered by hormones.

Effects of low-dose norethindrone acetate plus ethinyl estradiol (0.5 mg/2.5 microg) in women with postmenopausal symptoms: updated analysis of three randomized, controlled trials. [2006.06]
BACKGROUND: Based on the potential risks of post-menopausal hormone therapy (HT) found by the Women's Health Initiative, guidelines for HT now recommend use of the lowest effective dose and shortest treatment duration consistent with individual treatment goals. Current (2003) guidance established by the US Food and Drug Administration (FDA) recommends that clinical assessments of HT include women with more frequent and more intense vasomotor symptoms than previously studied. Therefore, this analysis was conducted to further assess the efficacy of a low-dose combination of norethindrone acetate and ethinyl estradiol (NA/EE) previously assessed in dose-ranging studies, while meeting conservative FDA trial design and analysis criteria. OBJECTIVES: The aim of this post hoc analysis and overview was to present data on the efficacy and tolerability of a low-dose combination-NA/EE 0.5 mg/2.5 microg-in the treatment of postmenopausal symptoms, based on data from previously published studies of NA/EE. In addition, the effects of low-dose NA/EE on bone and endometrium are briefly reviewed... CONCLUSIONS: The results from this post hoc analysis and overview of 3 previously published studies suggest that NA/EE 0.5 mg/2.5 microg was associated with decreased frequency and intensity of vasomotor symptoms. This dose of NA/EE was also associated with maintenance of BMD over 24 months, a significant positive effect on BMD compared with placebo. Low-dose NA/EE was also associated with cumulative amenorrhea rates comparable to those of placebo and was not associated with endometrial hyperplasia. This dose was well tolerated, with rates of adverse events generally similar to those of placebo.

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Clinical Trials Related to Aygestin (Norethindrone)

The Effect of Atazanavir and Ritonavir on the Pharmacokinetics of Oral Norethindrone [Recruiting]
The purpose of this study is to learn if women taking the atazanavir and ritonavir have lower levels of a birth control medication called norethindrone. Norethindrone (also called the mini pill) is an FDA (Food and Drug Administration) approved progestin-only birth control pill used to prevent pregnancy. Norethindrone is the standard medication used in women who take the progestin only pill to prevent pregnancy. There are other birth control pills which contain different medications. The investigators want to learn if HIV medications (atazanavir and ritonavir) make the blood level of this birth control pill higher or lower. If the levels of norethindrone are too low it may not work to prevent pregnancy. The investigators also hope to learn about changes in the vaginal fluids and cervical fluids when women are taking this birth control pill.

Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding [Recruiting]
Problematic uterine bleeding after the insertion of the LNG IUS is a well documented side effect. The levonorgestrel intrauterine system (LNG IUS) was approved for treatment of heavy menstrual bleeding (HMB) by the FDA in October 2009. To reduce the incidence and severity of post-insertional uterine bleeding, pretreatment with norethindrone acetate may effectively slough the endometrium prior to insertion of the LNG IUS.

Treatment of Endometriosis With Norethindrone Acetate ( NA) VS. Gonadotropin- Releasing Hormone (GnRH) Agonist (Lupron Depot 11.25 mg) [Recruiting]
(A) Major 1) to compare the effectiveness of norethindrone acetate (NA) with GnRH agonist (Lupron-Depot-3) in relieving symptoms of endometriosis, 2) to compare bone density in the two treated groups in order to demonstrate that NA does not affect bone density; (B) Minor: 1) To compare the lipid profiles of patients in the two groups to confirm the hypothesis that the effects of NA and GnRH agonists on lipid profiles are similar, 2) To determine whether quality of life, assessed by questionnaire, is better in patients assigned to NA than in patients assigned to GnRH, 3) To determine whether NA has fewer adverse effects than GnRH agonist.

Observational Study to Investigate the Occurrence of Bleeding in Postmenopausal Women Treated With 0.5 mg Estradiol and 0.1 mg Norethisterone Acetate for 12 Months [Recruiting]
This study is conducted in Europe. The primary aim of this observational study is to investigate the occurrence of bleeding in women taking 0. 5 mg estradiol and 0. 1 mg norethisterone acetate for 12 months.

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.

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Reports of Suspected Aygestin (Norethindrone) Side Effects

Breast Cancer (2)Breast Cancer Female (2)Deep Vein Thrombosis (2)Night Sweats (1)Anaphylactic Shock (1)Pulmonary Embolism (1)Headache (1)Vaginal Haemorrhage (1)Abdominal Discomfort (1)Chest Pain (1)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 3 ratings/reviews, Aygestin has an overall score of 6.33. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

Aygestin review by 50 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   hormone balance
Dosage & duration:   10 mg /day taken daily for the period of 2years
Other conditions:   na
Other drugs taken:   none
  
Reported Results
Benefits:   very beneficial. no issues or side effects and my monthly period became more normal versus very heavy bleeding. i'm still on the medication and will continue as directed until full menapause.
Side effects:   I had no side effects wtih this drug. not sure how much more clear I can make it.
Comments:   took prescrition daily and that was it. pretty simple.

 

Aygestin review by 19 year old female patient

  Rating
Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   endometriosis
Dosage & duration:   5mg taken everyday for the period of 5 months
Other conditions:   fibromyalgia
Other drugs taken:   opana
  
Reported Results
Benefits:   well it was supposed to stop my painful periods from my endometriosis and its suposed to stop my endometriosis from growing.
Side effects:   depression, nausea, anxiety, heart racing, still in pain, still having painful breakthrough bleeding.
Comments:   well ive been takin it everyday for 5 months and if one more doctor tells me "its gonna take some time" im going to break something. i start college soon (again, had to drop out due to my painful constant periods) so im getting real tired of feeling like dirt all of the time. its supposed to make everything better and it hasnt done jack crap. i also have to take opana for the pain (morphine pills) and im going into medical school and they dont like drugs in youre system

 

Aygestin review by 19 year old female patient

  Rating
Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   endometriosis
Dosage & duration:   5mg taken everyday for the period of 5 months
Other conditions:   fibromyalgia
Other drugs taken:   opana
  
Reported Results
Benefits:   well it was supposed to stop my painful periods from my endometriosis and its suposed to stop my endometriosis from growing.
Side effects:   depression, nausea, anxiety, heart racing, still in pain, still having painful breakthrough bleeding.
Comments:   well ive been takin it everyday for 5 months and if one more doctor tells me "its gonna take some time" im going to break something. i start college soon (again, had to drop out due to my painful constant periods) so im getting real tired of feeling like dirt all of the time. its supposed to make everything better and it hasnt done jack crap. i also have to take opana for the pain (morphine pills) and im going into medical school and they dont like drugs in youre system

See all Aygestin reviews / ratings >>

Page last updated: 2014-09-16

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