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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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
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
N/A N=49 Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
Premenstrual Syndrome
Primary: Comparison of the Change in IDS Symptom Scores Among Groups — 31.85; 30.92; 28.85; 14.08 units on IDS scale — p=0.07
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 4 N=252 Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder
Premenstrual Dysphoric Disorder
Primary: Premenstrual Tension Scale (PMTS) — 22.3; 21.4; 15.6; 16.8 units on a scale — p=0.21
N/A N=80 Premenstrual Dysphoric Disorder and Antiepileptic Drugs
Epilepsy
Primary: To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. — 0; 0; 0; 2 Participants
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 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 3 N=10 Emotional Processing and Oxytocin Mechanisms in Premenstrual Dysphoric Disorder: A Pilot Study
Premenstrual Dysphoric Disorder
Primary: Change in Premenstrual Symptom Severity — 25.05; 27.36 units on a scale
N/A N=32 The Oral Contraceptive Pill for Premenstrual Worsening of Depression
Premenstrual Syndrome · Depression
Primary: Percent Change in Luteal Montgomery-Asberg Depression Rating Scale (MADRS) — -43.6; -38.9 percent change — p=.59
Phase 4 N=45 The Role of GABA and Neurosteroids in Premenstrual Dysphoric Disorder
Premenstrual Dysphoric Disorder · Premenstrual Syndrome
Primary: Change in Cortical Gama-aminobutyric Acid Levels (GABA Levels) Pre and Post SSRI Treatment
N/A N=68 Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms
PMS · Menstrual Pain
Primary: Relief From Premenstrual Cramps [Time Frame: Baseline to 3 Months] — 4.41; 3.48; 3.12; 2.72 score on a scale — p=<0.001
Phase 4 N=67 Continuous Oral Contraceptive Treatment in Premenstrual Dysphoric Disorder (PMDD)
Premenstrual Dysphoric Disorder
Primary: Pre-Post Change in Premenstrual Symptom Severity — 1.93; 1.73; 1.64 units on a scale
N/A N=36 Neurophysiology of Postpartum Depression in an Experimental Model of Pregnancy and Parturition
Postpartum Depression
Primary: Blood-oxygen-level-dependent (BOLD) Response During Functional Magnetic Resonance Imaging (fMRI) z Statistic — 2.3; 2.0; 2.1; 1.7 z score — p=.27
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 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
N/A N=8 Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women
Healthy
Primary: To Determine the Impact of GABA-A Receptor Agonists (Benzodiazepines, Allopregnanolone) and Other GABA-modulating Agents (Fluoxetine) on Cortical GABA Levels by…
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=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
Phase 2 N=15 The Role of Hormones in Postpartum Mood Disorders
Postpartum Depression
Primary: Edinburgh Postnatal Depression Scale (EPDS) Mean Total Score — 3.75; 3; 0; 1.14 Units on a scale
Phase 4 N=71 Prospective Survey of Menstrual Migraine & Prevention With Eletriptan
Migraine
Primary: Change in Mean Headache Index Score Among Patients — -1.52 headache index score
Phase 3 N=570 24-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms
Hot Flashes
Primary: Mean Change From Baseline in Hot Flash Frequency at Week 4 and Week 12. — 10.83; 10.90; -4.13; -2.71 Hot flashes per day — p=<0.0001
N/A N=24 Omega-3 for Peri- and Postmenopausal Depression
Depression
Primary: Change in MADRS Score — 12.0 units on a scale
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 3 N=45 Cinnamon Extract on Menstrual Cycles in PolyCystic Ovary Syndrome (PCOS)
Polycystic Ovary Syndrome
Primary: Number of Menses During the Six Month Study Period. — .42; .42; .75; .25 Number of menstrual cycles per month
Early Phase 1 N=8 Progesterone for Cannabis Withdrawal
Cannabis Use Disorder · Cannabis Withdrawal
Primary: Change in Salivary Progesterone Level — 237.86; 97.87 pg/ml
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 2 N=23 Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model
Perinatal Depression · Post Partum Depression · Depression, Postpartum
Primary: Mean Threat Processing Bias During Visual Dot-probe Paradigm Over Time — -0.57; 36.92; -9.04; -42.35 attention bias in milliseconds — p=0.160
Phase 3 N=614 Efficacy/Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms (VMS)
Postmenopausal Symptoms
Primary: Mean Change in Frequency of Moderate to Severe VMS From Baseline at Week 4 and Week 12. — 11.79; 11.65; -4.71; -3.36 Hot flash per day — p=<0.0001