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Norethisterone Medical Research Studies

Up-to-date List of Norethisterone Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Norethisterone Medical Research Studies

Rank Status Study
1 Recruiting The Effect of Protease Inhibitors on the Pharmacokinetics of Oral Norethindrone Contraception
Conditions: Pregnancy;   HIV;   AIDS
Intervention: Drug: Norethindrone acetate
Outcome Measure: AUC norethindrone
2 Unknown  Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding
Conditions: Heavy Menstrual Bleeding;   Menorrhagia;   Hypermenorrhea
Interventions: Drug: Norethindrone acetate pretreatment;   Other: No pretreatment
Outcome Measures: Total number of bleeding days;   Menorrhagia Questionnaire
3 Not yet recruiting Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325
Condition: Hepatitis C
Interventions: Drug: FDC of Daclatasvir, Asunaprevir and BMS-791325;   Drug: FDC of Norethindrone and Ethinyl Estradiol;   Drug: BMS-791325
Outcome Measures: Area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone;   Maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone;   Dose-normalized area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone;   Dose-normalized maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone;   Time of maximum observed plasma concentration (Tmax) of Ethinyl Estradiol and Norethindrone;   Safety measured by occurrence of Adverse events (AEs), serious AEs and AEs leading to discontinuation;   Safety measured by abnormalities in vital sign measurements;   Safety measured by findings on Electrocardiogram (ECG) measurements and physical examinations;   Safety measured by marked abnormalities in clinical laboratory test results
4 Unknown  The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial
Condition: Endometriosis
Interventions: Drug: Conjugated equine estrogens;   Drug: Placebo;   Drug: Norethindrone acetate
Outcome Measures: Bone mineral density;   Volumetric bone mineral density;   Quality of life
5 Recruiting Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
Conditions: Heavy Uterine Bleeding;   Uterine Fibroids
Interventions: Other: Placebo;   Drug: Elagolix;   Drug: Estradiol/norethindrone acetate, E2/NETA;   Drug: Estradiol/norethindrone acetate, E2/NETA Dose 2;   Drug: Estradiol/norethindrone acetate
Outcome Measures: Change in Menstrual Blood Loss;   Change in Physical Examination;   Change from Baseline in the number of subjects with adverse events;   Change in Bone Mineral Density (BMD);   Change in Endometrial Assessment;   Change in Clinical Laboratory Tests;   Percentage of Subjects with reduction in Menstrual Blood Loss;   Percentage Subjects with amenorrhea;   Percentage of Subjects with No Bleeding (spotting allowed);   Number of Bleeding Days;   Percent Change from baseline in bleeding scores per bleeding diary;   Percent Change in Uterine Volume;   Percent Change in Fibroid Volume;   Percent change in hemoglobin concentration;   Change in bone mineral density;   Change in percentage of subjects with hypoestrogenic effects;   Proportion reporting treatment-emergent adverse events;   Change from Baseline in the percent of subjects with adverse events
6 Not yet recruiting A Pharmacokinetics, Pharmacodynamics, and Safety Study of an Oral Contraceptive Containing Norethindrone and Ethinyl Estradiol When Co-administered With GSK1322322 in Healthy Adult Women
Condition: Infections, Bacterial
Interventions: Drug: GSK1322322;   Drug: EE/NE;   Drug: GSK1322322 Placebo;   Drug: EE/NE Placebo
Outcome Measures: Composite of PK parameters of EE/NE to compare the steady state plasma PK. If data permit, after EE/NE alone for 7 days and after EE/NE with GSK1322322 for 7 days.;   Composite of PK parameters of GSK1322322 following co-administration of GSK1322322 and EE/NE for 7 days;   Number of subjects with adverse events (AEs) as a measure of safety and tolerability;   Concurrent medication assessment as a measure of safety and tolerability;   Laboratory parameter assessment as a measure of safety and tolerability;   Electrocardiogram (ECG) assessment as a measure of safety and tolerability.;   Vital sign measurement as a measure of safety and tolerability;   Pre-dose serum level of Lutenizing Hormone (LH).;   Pre-dose serum level of Follicle stimulating hormone (FSH);   Pre-dose serum level of Progesterone
7 Recruiting HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas: Zim CHIC
Conditions: Contraception;   HIV;   Immune Cells (Mucosal and Systemic);   Microbiota
Interventions: Drug: DMPA;   Drug: NET-EN;   Drug: MPA/E2;   Device: LNG-I;   Device: ENG-I;   Device: Cu-IUD
Outcome Measures: Genital tract CD4 cells (number and % expressing CCR5);   Vaginal microbiota (key microbes);   Serum hemoglobin;   Serum concentration of estradiol and progesterone/progestin
8 Recruiting Gender Disparity and Hormones in Cystic Fibrosis
Condition: Cystic Fibrosis (CF)
Intervention: Drug: Loestrin (norethindrone acetate and ethinyl estradiol)
Outcome Measure: Change in percent predicted forced expiratory volume in 1 second (FEV1)
9 Recruiting Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition
Conditions: Relapsing-remitting Multiple Sclerosis;   Secondary-progressive Multiple Sclerosis;   Primary-progressive Multiple Sclerosis
Interventions: Drug: estriol;   Other: Placebo;   Drug: Norethindrone;   Other: Progestin Placebo
Outcome Measures: Change from baseline in cognitive function assessed by Paced Serial Addition Test (PASAT).;   Change from baseline in cognitive function as assessed by cognitive evoked potentials, measured in milliseconds.;   Change from baseline in standard MS outcome measures.;   Determine safety by assessing the number of subjects with adverse events with combination treatment as compared to placebo.;   Change from baseline in cognitive function as assessed by a brief battery of cognitive tests.
10 Unknown  Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen
Conditions: Endometrial Hyperplasia;   Endometrial Cancer
Interventions: Drug: progesterone;   Drug: activella
Outcome Measures: Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups.;   Comparison of the proportion of bleeding pattern between the two groups.;   To demonstrate that vaginal progesterone tablets decrease systemic progesterone adverse reactions using a questionnaire.
11 Recruiting Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation
Condition: Oral Contraceptive
Interventions: Drug: Oral Contraceptive: Ortho-Novum® 1/35;   Drug: Oral Contraceptive: Ovcon® 35;   Drug: Oral Contraceptive: Microgestin Fe® 1/20
Outcome Measure: To measure breast cell proliferation levels between the three oral contraceptive dose groups.
12 Recruiting Preservation of Ovarian Function After Hematopoietic Cell Transplant
Conditions: Multiple Myeloma;   Non-Hodgkin Lymphoma;   Hodgkin Disease;   Acute Myeloid Leukemia;   Myeloproliferative Disorders
Interventions: Drug: Leuprolide;   Biological: hematopoietic cell transplant;   Biological: reduced intensity allogeneic HCT
Outcome Measures: Comparison of Number of Patients with Ovarian Failure;   Comparison of Number of Participants Who Stopped Menstrual Bleeding;   Comparison of Follicle Stimulating Hormone (FSH) Levels;   Comparison of Number of Participants Who Resumed Menstrual Cycles;   Comparison of Leuprolide Hormone (LH) Levels;   Comparison of Antimullerian Hormone (AMH) Levels After Transplant

These studies may lead to new treatments and are adding insight into Norethisterone etiology and treatment.

A major focus of Norethisterone research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.

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