Estradiol

Adverse event collection

PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs

ongoing pregnancy rate

Characteristic Pain Intensity (Characteristic Intensity of Facial Pain)

Endometrial thickness (ET)

clinical pregnancy rate per initiated ART cycle

Vascular function

Restoration of Regular Menstrual Cycles

Serum androgen

clinical pregnancy

Incidence of adhesion information

the endometrial thickness

Associations between elevated E2 concentration and acute stress effects on subjective experience

Flow-mediated dilation of the brachial artery

Insulin-mediated Glucose Disposal Rate (Hyperinsulinemic-euglycemic Clamp)

To compare the effects of two EP combinations on endocrine-metabolic parameters in normal weight PCOS women

Bleeding on probing (BOP)

Change in the Matsuda index from the circulating glucose and insulin concentrations during and standard oral glucose tolerance test.

flow-mediated dilation

Changes in plasma estradiol levels

Number of Participants With Grade 4 Toxicity

Prevalence of Urinary Tract Infections (UTI)

Change in Carotid Baroreflex Sensitivity (Bpm/mmHg)

For the bleeding evaluation, subject will be given a diary card to record the days on which no bleeding, vaginal spotting or bleeding occurs

Number of Participants With Regular Menstrual Cycles

Bone mineral density

Change from Baseline in Activated recalcification time

Change in left ventricular relaxation rate

Brachial artery flow mediated dilation (FMD)

Total Female Sexual Function Index (FSFI) score

Storage symptom improvement

number of egg retrievals on weekend days

Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC).

Comparison of microscopic hematuria (RBC's) at 12 weeks compared to baseline measurement

Peripheral Insulin Sensitivity at Baseline and 6 Months.

Change in the Microdialysis Cortisone Challenge (MCC) Index

The relative change in the frequency of hot flushes

Change in Weight From Baseline at 12 Months

follicle development

Number of Participants With Follicle Rupture

Occurrence of UTI During Randomization

change in serotonin-transporter binding potential (BP) in predefined brain regions, measured by Positron Emission Tomography

Brachial Artery Reactivity % Flow Mediated Dilation (BAR %FMD)

Progression-Free Survival

Number of In-Treatment Pregnancies Per 100 Woman-Years of Exposure in Participants 18-35 Years of Age (Pearl Index)

Number of In-Treatment Pregnancies Per 100 Woman-Years of Exposure in Participants 18-35 Years of Age (Pearl Index)

Pearl Index

Pearl Index, 18-35 Years, MITT Population

Occurrence of pregnancy

Contraceptive Efficacy Assessed by Pearl Index in Participants Aged ≤35 Years

Contraceptive efficacy of the 2 treatments was estimated by determination of pregnancy rates, using the Pearl Index and life table analysis (cumulative probability of pregnancy). Safety was evaluated throughout the study.

Contraceptive Efficacy Using the Pearl Index for All Subjects

Number of pregnancies (evaluable cycles)

The primary efficacy variable is the number of unintended pregnancies as measured by the Pearl Index (PI) during 13 cycles of treatment

Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population

Percentage Of Participants Who Meet The Dysmenorrhea Responder Criteria At Week 52

Mean change in systolic office blood pressure measured at through

Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)

Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment

Change from baseline to cycle 4 in the sum of composite score during cycle days 22 - 28. The composite score comprises headache, pelvic pain and bloating (each measured by 7-point Likert scales).

Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Final Assessment

The Primary Efficacy Endpoint

Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score

Number of migraine days

Relief of vaginal symptoms

Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms

live birth rate

Relative change in frequency of hot flushes

Vulvovaginal Symptoms

Relief of vaginal symptoms

Hot flush (frequency and severity)

Resting Energy Expenditure (REE)

Ovulation

Evaluate the efficacy of one-time topical estrogen application for reducing postoperative health system contacts for vaginal bleeding in the first two weeks post hysterectomy.

Compare differences in hormone patterns (follicle stimulating hormone [FSH], luteinizing hormone [LH], inhibin-B, and estradiol)

Implantation rate

Number of migraine attacks

Number of intracyclic bleeding episodes during cycles 2 to 7

Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month

Recording of vaginal bleeding events (diary) as a measure of Cycle control

Number of bleeding/spotting days/episodes per treatment cycle

Percentage of participants who are UTI-free at 6 months

The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3, based on the binary variable ovulation (i.e. Hoogland score 6) with the levels yes and no

Center for Epidemiologic Studies-Depression (CES-D) Scale Mean Total Score

hormonal implant and PENTRAVAN transdermal gel pharmacokinetics

Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Parabasal Cells)

Prostate Specific Antigen (PSA) Response Rate: Number of Subjects With Decreases in PSA of at Least 50%

Percent Change in Bone Mineral Density (BMD) of Lumbar Spine by Dual Energy X-ray Absorptiometry (DXA)

Early-Luteal-to-Perimenstrual Worsening of Daily Passive Suicidal Ideation (PSI)

Change From Pre-intervention to Intervention Endpoint in Weekly Average Binge-eating Frequency

Change in Premenstrual Tension Syndrome Scale (PMTS) Factors Associated With Premenstrual Symptoms.

Number of participants with Major Depression Disorder

The thickness of the endometrium

Impact of exogenous administration of estradiol on the neural correlates of fear extinction

Evaluate the pharmacokinetic drug interaction between folic acid and OC (250 mcg NGM and 35 mcg EE) as measured by the pharmacokinetics of the active breakdown products of NGM, (norelgestromin [NGMN], and norgestrel [NG]) and EE.

The area under the ethinylestradiol plasma concentration time curve at steady state

Total Ethinyl estradiol: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72)

Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t)

Pharmacokinetic sampling over the course of 4 days following two different formulations of the same compound

Plasma concentrations of NOMAC and serum concentrations of E2 and E1 measured at several time points before, during and after multiple dose and after single dose administration to determine pharmacokinetics

Baseline-Adjusted Area Under the Serum Concentration- Time Curve from Time Zero to Last Quantifiable Sampling Time After Administration (AUC0-tlast,adj) for both r-hFSH and r-hLH

Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of EE and LNG

Levonorgestrel (LNG) concentration in plasma

To determine the effect of co-administration of atazanavir 300 mg and ritonavir 100 mg on the pharmacokinetics of ethinyl estradiol

AUC0-t

PK of the Oral contraceptive agent

Maximum Observed Plasma Concentration (Cmax) of Midazolam and 1-hydroxymidzolam

Number of Participants with Adverse Events (AEs)

Area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone

Gene expression (RNAseq analysis of gene expression from needle bone biopsies)

Maximum Observed Plasma Concentration of Drospirenone (Cmax)

AUCinf for EE

Total Ethinyl estradiol: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72) ]

Red blood cell flux

Pessary Discontinuation Rates