NOR-QD SUMMARY
WatsonPharma
13536-2
Physician Labeling
Nor-QD® Tablets
(norethindrone 0.35 mg tablets, USP)
Rx only
Each yellow NOR-QD® tablet provides a continuous oral contraceptive regimen of 0.35 mg norethindrone daily, and the inactive ingredients include D&C Yellow No. 10, FD&C Yellow No. 6, lactose, magnesium stearate, povidone, and starch.
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.
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NEWS HIGHLIGHTSMedia Articles Related to Nor-QD (Norethindrone)
US funding revamps African contraceptive drive (AFP)
Source: Y! Health News Search RSS Feed [2009.11.18]
AFP - A new 12 million dollar family planning drive launched here Wednesday highlights how Obama administration funding has revamped a contraception drive in Africa and developing states, UN officials said, noting a sharp turnaround from the Bush era.
Terrence Higgins Trust Welcomes Department Of Health Nursing Degree Announcement, UK
Source: HIV / AIDS News From Medical News Today [2009.11.15]
HIV and sexual health charity Terrence Higgins Trust has welcomed the announcement by the Department of Health that all new nurses will be educated to degree level from 2013. Terrence Higgins Trust (THT) currently employs nurses who work in Chlamydia screening programmes for young people, HIV testing clinics and clinics that offer contraception services and screening for sexually transmitted infections.
Published Studies Related to Nor-QD (Norethindrone)
Endometrium protection and acceptability of nasally administered continuously combined hormone therapy: a multicentre, multinational, double-blind trial in post-menopausal women evaluating three regimens of 17beta-estradiol and norethisterone when compared with an orally administered 17beta-estradiol norethisterone regimen. [2009.07]
BACKGROUND: To determine the optimal daily dose of intranasal hormone therapy (HT) in order to achieve adequate endometrial protection... CONCLUSIONS: HT using a fixed intranasal dose of 350 microg E2 combined with 550 microg NET is a safe regimen, in relation to 1 year endometrial safety. This regimen is associated with less vaginal bleeding when compared with an oral comparator using 2 mg E2 and 1 mg NET.
Angeliq versus Activelle in normotensive postmenopausal women: a prospective, randomized pilot study. [2009.07]
OBJECTIVE: The aim of this study was to compare, in normotensive postmenopausal women, the effects of drospirenone/estradiol and norethisterone acetate/estradiol on blood pressure and other surrogate markers of cerebrovascular and cardiovascular risk... CONCLUSIONS: A 6-month hormone therapy with drospirenone/estradiol or norethisterone acetate/estradiol is equally effective and does not seem to alter the surrogate markers of cardiovascular and cerebrovascular risk.
A Canadian, multicentre study comparing the efficacy of a levonorgestrel-releasing intrauterine system to an oral contraceptive in women with idiopathic menorrhagia. [2009.04]
OBJECTIVES: To evaluate the efficacy of a levonorgestrel-releasing intrauterine system (LNG-IUS) compared with a combined oral contraceptive containing 1 mg norethindrone acetate and 20 mg ethinyl estradiol (OC1/20) in reducing menstrual blood loss (MBL) in women with idiopathic menorrhagia... CONCLUSION: Both the LNG-IUS and the combined oral contraceptive effectively decreased menstrual blood loss in women with idiopathic menorrhagia. The overall clinical benefit was more pronounced with LNG-IUS than with OC1/20.
The effects of continuous combined oral estradiol and norethisterone on pulsatility index in internal carotid and uterine arteries in early postmenopausal Taiwanese women---a preliminary study. [2009.03]
OBJECTIVE: This study analyzed whether continuous combined oral estradiol and norethisterone had any effect on the pulsatility index (PI) of the internal carotid and uterine arteries in Taiwanese early postmenopausal women. MATERIALS AND METHODS: A group of 40 healthy postmenopausal women with no history of hormone therapy (HT) participated in this study and were randomly subdivided into two groups: HT treatment group (n = 20) and placebo group (n = 20)...
Low-dose oral contraceptive pill for dysmenorrhea associated with endometriosis: a placebo-controlled, double-blind, randomized trial. [2008.11]
OBJECTIVE: To evaluate the efficacy of a low-dose oral contraceptive pill (OCP) for patients with dysmenorrhea associated with endometriosis... CONCLUSION(S): The present study clearly demonstrated for the first time that OCPs could be used to effectively and safely treat pain associated with endometriosis.
Clinical Trials Related to Nor-QD (Norethindrone)
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.
TMC278-TiDP6-C136: Effect of TMC278 on Ethinylestradiol and Norethindrone in Healthy Women. [Recruiting]
The purpose of this study is to investigate the pharmacokinetic interaction between the
combination of ethinylestradiol and norethindrone and TMC278 25 mg once daily.
Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body
and eliminated from the body. Furthermore the short-term safety and tolerability (how well
the body tolerates the drug) of co-administration of TMC278 and ethinylestradiol and
norethindrone, in healthy women, will be assessed.
The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial [Recruiting]
The purpose of this study is to determine whether a regimen of norethindrone acetate +
placebo or norethindrone acetate + conjugated estrogens is superior in maintaining skeletal
health and quality of life in adolescents treated with a GnRH agonist for endometriosis.
The Effect of the Mini-Pill on Blood Factors in Women at Increased Risk for Forming Blood Clots [Recruiting]
We propose a prospective cohort study to assess the effect of the progesterone only
contraceptive pill (minipill) on coagulation parameters known to be associated with risk of
thrombosis (blood clots) in women who are at increased risk for forming blood clots. We
plan to recruit women with a history of venous thromboembolism (VTE, blood clot in a vein)
and women with a history of blood tests which demonstrate an increased risk of thrombosis
who desire contraception.
Women enrolled in this study will undergo phlebotomy (blood draw) at baseline (prior to
starting the minipill), one and three months. Stored samples will be used to measure
D-dimer, C-reactive protein (CRP), antithrombin (AT), factor VIII, free and total protein S,
fibrinogen, von Willebrand factor (vWF) and normalized activated protein C sensitivity ratio
(nAPCsr). Both groups will undergo a general physical and GYN exam prior to enrollment.
This exam and the blood testing will be provided free of charge. Patients will not be
prescribed the minipill after completion of the study and will be advised to consult with
their primary care physician or hematologist if they wish to continue this medication.
Medical Treatment of Endometriosis-Associated Pelvic Pain [Recruiting]
The Specific Aim of this project is to compare the efficacy and cost-effectiveness of
continuous oral contraceptives versus leuprolide/norethindrone in the treatment of
endometriosis-associated chronic pelvic pain. This comparison will be based on a randomized,
double-blind, trial of women with chronic pelvic pain who have been diagnosed with
endometriosis at the time of surgery within the last 3 years. We hypothesize that, over a
12-month period of postoperative treatment, the efficacy of oral contraceptives is no worse
than leuprolide/norethindrone, and that treatment with oral contraceptives is more
cost-effective.
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