CAMILA SUMMARY
Each light pink norethindrone tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily.
1. Indications:
Progestin-only oral contraceptives are indicated for the prevention of pregnancy.
2. Efficacy:
If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills.
|
|
NEWS HIGHLIGHTS
Published Studies Related to Camila (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.
Clinical Trials Related to Camila (Norethindrone)
Treatment of Endometriosis With Norethindrone Acetate ( NA) VS. Gonadotropin- Releasing Hormone (GnRH) Agonist (Lupron Depot 11.25 mg) [Active, not 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.
Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone [Completed]
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
pharmacokinetics (PK) of a single dose of contraceptive in healthy post-menopausal women.
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.
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions [Completed]
This study compared the relative bioavailability (rate and extent of absorption) of 0. 4
mg/35 mcg Norethindrone and Ethinyl Estradiol Chewable Tablets by Teva Pharmaceuticals, USA
with that of 0. 4 mg/35 mcg OvconŽ 35 Fe Chewable Tablets manufactured by Warner Chilcott
Company, Inc., following a single oral dose (2 * 0. 4 mg/35 mcg chewable tablets) in healthy
female adult volunteers administered under fasting conditions.
The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception [Completed]
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.
|
|
|
|
Page last updated: 2010-10-05
|
