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Vivelle Medical Research Studies

Up-to-date List of Vivelle 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 Vivelle Medical Research Studies

Rank Status Study
1 Recruiting Estradiol Levels in Patients Treated With Estring
Condition: Estrogen Levels Among Breast Cancer Patients
Intervention: Drug: Estradiol
Outcome Measures: Serum Estradiol;   Vaginal Dryness
2 Recruiting Efficacy and Safety Of Spil's Estradiol Vaginal Tablet
Conditions: Vulvar Atrophy;   Vaginal Atrophy
Intervention: Drug: Estradiol
Outcome Measures: Vaginal pH;   Symptoms of vulvar and vaginal atrophy
3 Recruiting Effects of Anorexia Nervosa on Peak Bone Mass
Condition: Anorexia Nervosa
Interventions: Drug: RhIGF-1 with transdermal 17-beta estradiol;   Drug: Placebo and transdermal 17-beta estradiol
Outcome Measures: A significant increase in bone density over a 12-month period;   A significant improvement in bone microarchitecture parameters at the ultradistal radius and tibia over a 12-month period
4 Unknown  Prevention of Menstrual Migraines: Effects of Estrogen Add-back During the HFI in Patients Using Continuous Oral Contraceptives.
Conditions: Menstrual Migraines;   Menstrual Bleeding;   Menstrual Spotting
Intervention: Drug: Estradiol or Placebo
Outcome Measures: Primary Outcome Measure;   Secondary Outcome Measure
5 Recruiting Relationship Between the Menstrual Cycle and Heart Disease in Women
Condition: Coronary Heart Disease
Interventions: Drug: Ethinyl Estradiol-Levonorgestrel combination;   Drug: leuprolide acetate;   Drug: Estradiol;   Drug: Progesterone
Outcome Measures: Change from baseline in total cholesterol to high density lipoprotein cholesterol ratio following ovarian suppression and steroid replacement;   Change from baseline in total cholesterol to high density lipoprotein cholesterol ratio after estradiol and progesterone replacement;   Change from baseline in total cholesterol to high density lipoprotein cholesterol ratio after monophasic hormonal oral contraceptive use;   Change from baseline in serum low density lipoprotein cholesterol following ovarian suppression and steroid replacement;   Change from baseline in serum low density lipoprotein cholesterol after estradiol and progesterone replacement;   Change from baseline in serum low density lipoprotein cholesterol after monophasic combined hormonal oral contraceptive use;   Change from baseline in serum high density lipoprotein cholesterol following ovarian suppression and steroid replacement;   Change from baseline in serum high density lipoprotein cholesterol after estradiol and progesterone replacement;   Change from baseline in serum high density lipoprotein cholesterol after monophasic combined hormonal oral contraceptive use;   Change from baseline in serum triglycerides following ovarian suppression and steroid replacement;   Change from baseline in serum triglycerides after estradiol and progesterone replacement;   Change from baseline in serum triglycerides after monophasic combined hormonal oral contraceptive use
6 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
7 Not yet recruiting A Bioequivalence Study of Norgestimate /Ethinyl Estradiol (NGM/EE) Tablets Manufactured at 2 Different Facilities
Condition: Healthy
Interventions: Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process);   Drug: Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process)
Outcome Measures: Maximum Plasma Concentration (C[max]);   Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]);   Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]);   Time to Reach the Maximum Plasma Concentration (T[max]);   Percentage of AUC(0-infinity);   Elimination Half-life Period (t1/2);   Terminal slope (Lambda [z]);   Coefficient of Determination (r^2);   Adjusted Coefficient of Determination (r^2 adj.)
8 Not yet recruiting Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel and Ethinyl Estradiol When Co-administered With GSK1265744 in Healthy Adult Female Subjects
Condition: Infections, Human Immunodeficiency Virus and Hepatitis
Interventions: Drug: Ethinyl Estadiol;   Drug: Levonorgestrel;   Drug: GSK1265744
Outcome Measures: Plasma (AUC[0-tau]);   Safety and tolerability of 744 when given with and without OC as assessed by adverse events (AE);   Safety and tolerability of 744 when given with and without OC as assessed by clinical laboratory tests;   Safety and tolerability of 744 when given with and without OC as assessed by Electrocardiogram (ECG);   Safety and tolerability of 744 when given with and without OC as assessed by vital signs;   Composite of plasma pharmacokinetic (PK) parameters of 744;   Predose serum levels of Progesterone, Luteinizing hormone (LH) and follicle stimulating hormone (FSH);   Composite of plasma PK parameters of 744 - AUC(0-tau), Cmax, tmax, Ctau and CL/F
9 Recruiting A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms
Condition: Menopause
Interventions: Drug: Estradiol;   Drug: Progesterone;   Drug: Placebo
Outcome Measures: Primary Efficacy Endpoints: Vasomotor Symptoms (VMS Substudy);   Endometrial protection;   VMS Substudy
10 Recruiting Oestradiol Pre-treatment in an Ultrashort Flare GnRH Agonist/GnRH Antagonist Protocol in Poor Responders Undergoing IVF
Condition: Infertility
Interventions: Procedure: Oestradiol pre-treatment and combination of GnRH agonist/antagonist protocol;   Procedure: GnRH agonist or antagonist protocol without oestradiol pre-treatment
Outcome Measures: Live birth rate;   Clinical pregnancy rate;   Number of oocytes retrieved;   Top embryo quality at day 2;   Biochemical pregnancy;   Ectopic pregnancy;   Miscarriage rate
11 Recruiting Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition
Conditions: Hyperandrogenemia;   Polycystic Ovary Syndrome
Interventions: Drug: Progesterone;   Drug: Estrace (estrogen)
Outcome Measure: LH Pulse frequency as a function of day 7 progesterone
12 Not yet recruiting Study of the Effect of Testosterone and Estradiol on NP Responses to Acute and Chronic Salt Loading
Condition: Hypertension
Interventions: Drug: leuprolide acetate;   Drug: Anastrozole
Outcome Measures: NP levels in men with testosterone patch and low-salt diet;   NP levels in men with testosterone patch and high-salt diet;   NP levels in women with estradiol patch and low-salt diet;   NP levels in women with estradiol patch and high-salt diet;   NP levels in men with placebo patch and low-salt diet;   NP levels in men with placebo patch and high-salt diet;   NP levels in women with placebo patch and low-salt diet;   NP levels in women with placebo patch and high-salt diet;   Plasma Renin Activity (PRA) levels in women on estradiol on low-salt diet;   Aldosterone levels in men with testosterone on low-salt diet;   Plasma Renin Activity (PRA) levels in women on estradiol on high-salt diet;   Plasma Renin Activity (PRA) levels in women on placebo on low-salt diet;   Plasma Renin Activity (PRA) levels in women on placebo on high-salt diet;   Plasma Renin Activity (PRA) levels in men on testosterone on low-salt diet;   Plasma Renin Activity (PRA) levels in men on testosterone on high-salt diet;   Plasma Renin Activity (PRA) levels in men on placebo on low-salt diet;   Plasma Renin Activity (PRA) levels in men on placebo on high-salt diet;   Aldosterone levels in men on testosterone on high-salt diet;   Aldosterone levels in men on placebo on high-salt diet;   Aldosterone levels in men on placebo on low-salt diet;   Aldosterone levels in women on estradiol on high-salt diet;   Aldosterone levels in women on estradiol on low-salt diet;   Aldosterone levels in women on placebo on high-salt diet;   Aldosterone levels in women on placebo on low-salt diet;   Urinary sodium concentration in women on estradiol on high-salt diet;   Urinary sodium concentration in women on placebo on high-salt diet;   Urinary sodium concentration in men on testosterone on high-salt diet;   Urinary sodium concentration in men on placebo on high-salt diet
13 Recruiting Research Investigation of Soy and Estrogen
Conditions: Menopause;   Hot Flashes
Interventions: Dietary Supplement: Phytoestrogen;   Drug: Estradiol;   Drug: medroxyprogesterone acetate;   Other: Placebo
Outcome Measure: quality of life
14 Unknown  Clinical Estradiol Trial in Women With Schizophrenia
Conditions: Schizophrenia;   Schizoaffective Disorder;   Schizophreniform Disorder
Intervention: Drug: Estradiol
Outcome Measures: The change in psychotic symptoms as measured by Positive and Negative Symptom Scale (PANSS) over 4 week period;   Abnormal Involuntary Movement Scale at end of trial period;   Adverse Symptom Checklist at end of trial period;   Simpson Angus Scale at end of trial period;   Hormone Measurements at end of four week period;   Cognitive Measurements at end of trial period
15 Unknown  Effects of Estradiol on Menopausal Breast
Condition: Hormone Replacement Therapy
Intervention: Drug: Angemin vs Activelle
Outcome Measures: Mammographic breast density - classified according to digitized data-based quantification of breast density.;   Effects on serum levels of Oestradiol etc.
16 Recruiting Estradiol vs Lysteda in Treatment of Heavy Menstrual Bleeding
Condition: Menstrual Cycle and Uterine Bleeding Disorders
Interventions: Drug: Estradiol;   Drug: Lysteda
Outcome Measures: menstrual blood loss;   changes in local hemostatic factors
17 Unknown  The Influence of Estradiol Supplementation During the Luteal in Patients Undergoing IVF Treatment
Condition: Infertility
Intervention: Drug: Treatment with estradiol valerate
Outcome Measure: E2 and progesterone levels
18 Recruiting Clinical Trial of Estrogen for Postpartum Depression
Conditions: Postpartum Depression;   Depression
Intervention: Drug: 17 beta-estradiol
Outcome Measures: Edinburgh Postnatal Depression Scale (2) the 17-item Hamilton Depression Rating Scale (HDRS).;   Beck Depression Inventory (BDI), the Center for Epidemiologic Studies-Depression Scale (CES-D); visual analogue scale (VAS) measuring the reported severity of 15 mood and behavioral symptoms; SCID interview.
19 Recruiting Effect of Metformin on Sensitivity of the Gonadotropin-releasing Hormone (GnRH) Pulse Generator to Suppression by Estradiol and Progesterone
Conditions: Polycystic Ovary Syndrome;   Hyperandrogenism
Interventions: Drug: Metformin;   Drug: Progesterone;   Drug: estrace
Outcome Measure: Change in LH pulse frequency before and after Metformin treatment.
20 Recruiting Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception
Condition: Oral Contraceptive
Interventions: Drug: Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg;   Drug: Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg
Outcome Measures: The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment;   Menstrual Cycle Control;   Weight changes

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

A major focus of Vivelle 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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