Phase 4 N=34 Estrogen Variability and Irritability During the Menopause Transition
Menopause · Irritable Mood
Primary: Mean IDAS Ill Temper Scale Score Over Time — 6.19; 6.02 score on a scale — p=0.09
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=38 Mirena and Estrogen for Control of Perimenopause Symptoms and Ovulation Suppression
Menopausal and Other Perimenopausal Disorders
Primary: Hot Flashes — 10.3; 7.944 scores on a scale
Phase 2 N=25 Postmenopausal Women Estrogen and Progesterone Infusion
Postmenopause · Aging
Primary: Effect of Aging on Estrogen Negative Feedback on LH — -52.8; -53.2 % change from baseline — p=0.90
N/A N=30 Early Menopause Hormone Treatment and Cognition
Menopausal Syndrome
Primary: Changes in Brain Activation Patterns in Verbal Tasks Determined With the Functional Magnetic Resonance Imaging (fMRI) Scans — .14; .13; .05; .13 percent BOLD signal…
N/A N=92 Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women
Arterial Stiffening · Aging · Menopause
Primary: Arterial Stiffness (Carotid Artery Compliance) During Saline — 1.31; 1.34; 0.90; 1.02 mm2/mm Hg×10-1
Phase 3 N=172 Perimenopausal Estrogen Replacement Therapy Study
Perimenopause · Menopause · Depression
Primary: Change in Depressive Symptoms as Indicated by The Center for Epidemiologic Studies Depression Scale (CES-D) — 1.04; -1.02 units on a scale
Phase 4 N=64 Perimenopausal Effects of Estradiol on Reward Responsiveness
Perimenopausal Depression
Primary: Caudate Signal Intensity in Response to Reward During the MID fMRI Task at Pre-treatment — .027; .043 percent signal change — p=.620
Phase 1 N=20 A Treatment Study for Premenstrual Syndrome (PMS)
Premenstrual Syndrome · Menstruation Disturbances
Primary: Mean Beck Depression Inventory Score — 2.6; 3.0; 5.3; 3.6 score on a scale
N/A N=53 Timing Estrogen After MenoPaUSe
Insulin Resistance
Primary: Insulin-mediated Glucose Disposal Rate (Hyperinsulinemic-euglycemic Clamp) — 11.7; 11.5; 12.2; 10.7 mg/kg FFM/min
Phase 3 N=189 Progesterone for Perimenopausal Night Sweats
Hot Flushes · Night Sweats
Primary: Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks — 5.5; 7.1 Units of Vasomotor Symptom Score
Phase 4 N=63 Raloxifene and Rimostil for Perimenopause-Related Depression
Perimenopausal Depression · Depression
Primary: Center for Epidemiologic Studies-Depression Scale (CES-D) — 27.4; 29.1; 28.8; 24.6 Units on a scale
N/A N=410 MyMenoPlan: Online Resource for Improving Women's Menopause Knowledge and Informed Decision-making
Menopause · Premenopause · Postmenopause
Primary: Perceived Quality of Information — 4.1; 3.7 score on a scale — p=<.001
Phase 4 N=84 Stress & Premenstrual Symptoms Study
PMDD · Stress · Mood
Primary: Acoustic Startle Response (ASR) Magnitude Based on Menstrual Cycle Phase — 54.2; 53.7; 56.4; 53.3 t score — p=0.139
Phase 4 N=30 Effect of Perimenstrual Ovarian Steroid Supplementation on Perimenstrual Suicidality
Suicidal Ideation
Primary: Perimenstrual Change in Self-Injurious Thoughts and Behaviors Interview (SITBI) Suicidal Ideation Score — -.05; .35 units on a scale — p=.012
Phase 2 N=92 Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension
Postmenopause · Hypertension · Pre-Hypertension
Primary: Change From Baseline to Week 8 in Mean 24-hour SBP From the Ambulatory Blood Pressure Monitoring (ABPM) Measurements in Full Analysis Set (FAS) Population — -1.03…
Phase 2 N=92 The Effects of Reproductive Hormones on Mood and Behavior
Healthy Volunteers
Primary: Mean Beck Depression Inventory Score — 1.4; 1; 1.1 Units on a scale
Phase 2 N=29 Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women
Estrogen Deficiency · Cardiovascular Disease (CVD) · Functional Hypothalamic Amenorrhea
Primary: Rate of Change of Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry — 0.20; 0.25 change of RHI
N/A N=129 Premenstrual Hormonal and Affective State Evaluation (PHASE) Project
Premenstrual Dysphoric Disorder
Primary: Hormone Analysis — 70.7; 57.8; 114; 97.3 ng/mL
Early Phase 1 N=6 Investigation of Female Reproductive Hormone Dynamics During Adolescence
Menstruation Disturbances
Primary: Ovulation in Cycle 2 — 3; 2 Participants
Phase 4 N=29 Impact of Hot Flashes on Sleep and Mood Disturbance
Menopause · Depression · Hot Flashes
Primary: Percent Change in Wake After Sleep Onset (WASO) — 62 percent change — p=0.007
Phase 4 N=46 Unique Effects of Perimenstrual Estradiol or Progesterone Supplementation on Perimenstrual Suicidality
Suicidal Ideation
Primary: Cyclical Change in Suicidal Ideation (SI) Severity — -.22; -.05; .25 units on a scale — p=.002
Phase 2 N=73 A Neurosteroid Intervention for Menopausal and Perimenopausal Depression
Major Depressive Disorder · Menopause · Perimenopause
Primary: Montgomery-Asberg Depression Rating Scale (MADRS) — 26.2; 27.0; 15.7; 15.2 units on a scale — p=0.29
Phase 2 N=11 Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa
Anorexia Nervosa · Osteoporosis
Primary: Percent Change in Bone Mineral Density (BMD) of Lumbar Spine by Dual Energy X-ray Absorptiometry (DXA) — 2.0 percent change
Phase 3 N=249 Luteal vs Follicular Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer
Breast Cancer
Primary: Overall Survival — 2.14; 2.00 years
Phase 4 N=25 Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder
Premenstrual Syndrome
Primary: Change in Premenstrual Symptoms as Measured by the Premenstrual Tension Scale (PMTS) — -6.9; -5.5; -5.5; -8.3 score on a scale — p== 0.57
Phase 3 N=20 Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women
Menopause
Primary: Vaginal Cytokines at Baseline — 2.73; 3.19; 0.12; 0.04 pg/ug protein
Phase 3 N=558 Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause
Vaginal Atrophy
Primary: Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear — 1.04; 1.02; 2.78; 11.22 Percentage of superficial cells
Phase 2 N=40 Effect of Pre-operative Depo Medroxyprogesterone Acetate on Serum Anti-mullerian Hormone Level After Laparoscopic Ovarian Cystectomy of Endometriomas
Endometriosis
Primary: Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation — -56.86; -77.72; -36.69; -66.84 percentage of serum AMH change
Phase 2 N=102 Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause
Hot Flashes
Primary: Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 8 — 82.44; 83.18; 37.3; 28.5 Hot flashes — p=0.0177
N/A N=6 Effects of Estrogen Deficiency on Energy Expenditure
Obesity
Primary: Brown Adipose Tissue Activity — 3.9; 4.0 Standard uptake value (SUV) — p=0.84