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
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=123 Evaluation of Pharmacodynamic Effects on Ovulation and Cycle Control
Ovulation Suppression
Primary: Ovulation Suppression in Three Treatment Groups Over 3 Cycles — 36.5; 20.7; 11.5; 36.9 %of cycles with possible ovulation
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
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 1 N=12 Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle
Pregnancy · Contraception
Primary: Part 1: Serum Medroxyprogesterone Acetate (MPA) Concentration at Day 1 — 0.36; 0.67 nanograms (ng)/milliliter (mL)
Early Phase 1 N=40 Ovarian Function With ENG Implant and UPA Use
Contraception
Primary: Number of Participants With Ovulation With Implant-alone — 7; 0 Participants
N/A N=11 The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle
Ovulation (Follicular Rupture Yes/no) · Menstrual Cycles (Total Length, Bleeding Days) · Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P)
Primary: Menstrual Cycle Length — 28.5; 27.2 Days
N/A N=700 Ulipristal Emergency Contraception Used Before or After Ovulation
Contraception
Primary: Percentage of Pregnancies Prevented (PPP) — 77.5; 36.9 percentage of pregnancies prevented — p=<0.0001
Phase 2 N=666 A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)
Contraception
Primary: Percentage of Participants With Ovulation Incidence, by Cycle — 0; 0; 0; 0 Percentage of Participants
Phase 2 N=10 Elagolix for Fertility Enhancement Clinical Trial
Endometriosis · Unexplained Infertility
Primary: Number of Live Births — 3; 1 live births
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
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 3 N=3,066 Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
Estrogen Receptor Positive Breast Cancer · Progesterone Receptor Positive Tumor · Recurrent Breast Carcinoma
Primary: Disease-free Survival — 84.7; 86.6; 89 percentage of participants — p=0.1
Phase 1 N=29 Determining How Quickly Progesterone Slows LH Pulse Frequency
Normal · PCOS
Primary: LH Pulse Frequency — 1.31; 0.91; 1.33; 1.19 pulses/hour
N/A N=18 Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT
Unexplained Infertility · Polycystic Ovarian Syndrome · Anovulatory
Primary: LH Surge — 9; 9 Participants
N/A N=20 The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation
Ovulation · Luteal Development
Primary: Number of Cycles With Ovulation Dysfunction When Taken After Ovulation: Extended Luteal Phase — 1; 6; 5 Participants
N/A N=7 Mirena® IUD's Effect on Fallopian Tube Fimbriae and Ovarian Cortical Inclusion Cyst Cell Proliferation
Epithelial Ovarian Cancer
Primary: Cell Proliferation in the Fallopian Tube Fimbriae as Measured by Ki-67%+ — 8.3 percentage of positively stained cells
Phase 2 N=59 GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients
Amenorrhea · Premature Ovarian Failure · Ovarian Function Insufficiency
Primary: Number of Participants With Secondary Amenorrhea Following 3-month Depot Leuprolide — 37 participants
Phase 3 N=39 LutrePulse Hypogonadotropic Hypogonadism
Primary Amenorrhea With Hypogonadotropic Hypogonadism
Primary: Ovulation Rate — 1; 4; 5; 9 Participants — p=0.0120
Phase 4 N=10 The Role of Estrogen in Luteinizing Hormone Surge and Ovulation
Ovulation Disorder · Ovarian Cysts
Primary: Number of Participants With Progesterone Level Greater Than 1.5 ng/mL — 9; 10 Participants
Phase 3 N=2,858 A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy
Contraception · Female Contraception
Primary: All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule…
N/A N=20 Differential Effects of Clomiphene Citrate in Women Undergoing Superovulation
Mood
Primary: Follicular Cycle Total Behavioral Score for Calendar of Premenstrual Experiences (COPE) Self Assessment — 3; 5 units on a scale
Phase 3 N=65 Intervention to End Recurrent Unscheduled Bleeding Trial
Contraception · Bleeding
Primary: Number of Bleeding/Spotting Days With Use of Ulipristal Acetate as Measured by Daily Bleeding Diaries — 7; 12 days — p=0.002
N/A N=20 The Role of Cetrotide Acetate in Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in Oocyte Donors
Ovarian Hyperstimulation Syndrome
Primary: Volume of Ascites in the Abdomen is Indicative of the Severity of OHSS — 10 cc (volume of ascites)
Phase 3 N=3,597 A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy
Pregnancy Prevention
Primary: All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 91-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight — 2.82; 2.46; 4.54…
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
Phase 3 N=900 Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation
Pregnancy · Unexplained Infertility
Primary: Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH. — 9; 8; 34 number of multiples
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 3 N=48 Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)
Contraception
Primary: Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation — 0; 0; 0; 0 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…