Phase 3 N=1,700 Study of Safety and Efficacy of an Oral Contraceptive
Contraception
Primary: Pearl Index, 18-35 Years, MITT Population — 1.903 Pearl Index
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=1,683 Study of Safety and Efficacy of an Oral Contraceptive
Contraception
Primary: Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population, — 2.554 Pregnancy Rate
Phase 4 N=36 Oral Contraceptives in the Metabolic Syndrome
Metabolic Syndrome X · Insulin Resistance · Obesity
Primary: Changes in Insulin Sensitivity Associated With Oral Contraceptive (OC) Use Compared Among (1) Obese Women and (2) Lean Women — 4.36; 6.62; 3.82; 8.23 mIU/L
Phase 3 N=938 Study of Safety and Efficacy of an Oral Contraceptive
Prevention of Pregnancy
Primary: Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population — 1.823; 2.978 Pearl Index
N/A N=64 Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity
Hypothalamic-pituitary-ovarian Axis, Gonadotropins, Ethinyl Estradiol, Contraceptive Efficacy
Primary: Follicle-stimulating Hormone — 5.01; 5.86; 6.38 milli international units per milliliter — p=0.88
Phase 4 N=46 Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
Insulin Sensitivity · Cardiovascular Risk · Perimenopausal Disorder
Primary: Change From Baseline in Insulin Sensitivity — -1.91; -5.63 min ^ -1 / mIU / L
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
Phase 2 N=38 Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea
Dysmenorrhea
Primary: Change in Visual Analog Scale (VAS) Score — -74.8; -58.7 units on a scale — p=0.05
N/A N=82 Oral Contraceptive (OC) Estrogen Dose and Breast Proliferation
Oral Contraceptive
Primary: Breast Cell Proliferation Levels Between the Three Oral Contraceptive Groups — 8.5; 11.9; 7.5 Percent of cells staining for Ki67
N/A N=33 Oral Contraceptive (OC) Progestin Dose and Breast Proliferation
Oral Contraceptive
Primary: Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups — 7.5; 12.4 Percent of cells staining for Ki67
Phase 4 N=226 Obesity, Oral Contraception, and Ovarian Suppression
Ovarian Suppression
Primary: Risk of Oral Contraceptive (OC) Failure Due to Less Contraceptive-mediated Ovarian Suppression. — 54; 28; 11; 12 Participants
Phase 3 N=2,235 Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
Contraception
Primary: Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy — 2.44; 2.42; 1.77…
Phase 4 N=32 Oral Contraceptives and Body Mass Index
Body Weight · Contraceptive Usage
Primary: LNG Steady State at Baseline and Then Post-randomization — 3.82; 3.13; 3.01; 3.58 ng/mL
N/A N=131 A Study of Continuous Oral Contraceptives and Doxycycline
Contraceptives, Oral
Primary: Differences in Bleeding Patterns Between Study Groups. — 26.72; 31.86; 25.69; 18.84 days
Phase 3 N=1,166 Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles
Contraception
Primary: Number of Days With Bleeding Including Spotting — 41; 61; 66 days — p=<0.0001
N/A N=20 A 6-month Observational Study on Combined Oral Contraceptives and Body Weight in Pre-Menopausal Women With Overweight or Obesity
Contraceptive Usage · Overweight or Obesity · Body Weight Changes
Primary: Number of Premenopausal Women With Overweight/Obesity Who Initiated a COC vs. Continued NHC Use, Enrolled and Remained in This Study, and Completed Outcome Measures — 9…
Phase 4 N=26 Effects of Oral vs. Non-oral Contraceptives on the GH/IGF-1 Axis
Bone; Disorder, Development and Growth
Primary: Changes in Insulin-like Growth Factor-1 (IGF-1), IGF Binding Proteins (IGFBP-1, IGFBP-3), and Acid Labile Subunit (ALS) — 220.6; 228.7; 197.1; 221.4 ng/mL
Phase 3 N=72 Pericoital Oral Contraception With Levonorgestrel
Healthy
Primary: Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35) — 22.4 pregnancies per 100 woman years
Phase 1 N=30 A Pharmacokinetic Study of Colchicine With an Oral Contraceptive
Pharmacokinetics
Primary: Maximum Plasma Concentration of Norethindrone With Colchicine at Steady State (Cmax, ss) — 24.17 ng/mL
Phase 3 N=409 To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)
Contraception
Primary: The Change in Average of the 3 Highest Visual Analog Scale (VAS) Values of the Hormone Withdrawal-associated Symptoms Pelvic Pain or Headache During Cycle Days 22 to 28…
Phase 3 N=385 Efficacy and Safety Study for an Oral Contraceptive Containing Folate
Neural Tube Defects · Contraception · Oral Contraceptives (OC)
Primary: Red Blood Cell (RBC) Folate Level at 24 Weeks — 1406.91; 1022.21 nmol/L — p=<0.0001
Phase 1 N=22 A Study of the Effect of Dulaglutide on How the Body Handles Oral Contraceptive in Healthy Female Participants
Diabetes Mellitus, Type 2
Primary: Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Norelgestromin (NGMN) — 17900; 16000 picograms*hour/milliliter…
Phase 4 N=51 Continuous Versus Cyclical OCP Use in PCOS
Polycystic Ovary Syndrome
Primary: Change in Biochemical Hyperandrogenism From Baseline to 1 Month Post Yasmin Initiation — -15.38; -8.54 ng/dl
N/A N=197 Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial
Breast Feeding · Contraception
Primary: Number of Participants Who Continued to Breastfeed at 6 Months — 15; 14; 8; 9 participants
N/A N=85,109 International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC)
Contraception
Primary: Venous Thromboembolism (VTE); Hazard Ratio for DRSP-24 Day vs. Non-DRSP OCs — 19; 16; 101; 7 participants
Phase 3 N=115 Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea
Dysmenorrhea
Primary: Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) — 3.8; 3.6; 1.2…
N/A N=14 Hormonal Contraception and Vaginal Health
Contraceptive Usage · Vaginal Epithelial Disruption
Primary: Thickness of the Vaginal Epithelium (in mm)With Means and Standard Deviations Reported. — 0.01; -0.005; -0.02; .007 mm
Phase 2 N=1,361 A Multicenter Study to Evaluate the Effects of a 91-day Oral Contraceptive on Bone Mineral Density in Adolescent Females
Bone Mineral Density
Primary: Percent Change From Baseline to 12 Months in Lumbar Spine Bone Mineral Density (BMD) — 2.26; 1.45; 2.50 percent change
Phase 4 N=64 Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism
Polycystic Ovary Syndrome
Primary: Biochemical Assessment of Hyperandrogenism — 0.7; 0.7 Index — p=<.0001
Phase 2 N=293 A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women
Hemostasis · Oral Contraceptive
Primary: Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels — 45.0; 56.8 pmol/L — p=0.5892