E4/DRSP Ovarian Function Inhibition Study

Estetra

Status and phase

Completed

Phase 2

Conditions

Prevention of Pregnancy

Treatments

Drug: 20 mcg EE/3 mg DRSP

Drug: 15 mg E4/3 mg DRSP

Study type

Interventional

Funder types

Industry

Identifiers

NCT03091595

2016-004267-40 (EudraCT Number)

MIT-Es0001-C202

Details and patient eligibility

About

A combined oral contraceptive (COC) containing 15 mg E4 and 3 mg DRSP administered for 24 days followed by 4 placebo tablets, is being evaluated for further development. This study will investigate the effect of this COC on ovarian function inhibition, levels of serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol (E2) and progesterone during 3 treatment cycles in comparison with the reference COC 20 mcg EE/3 mg DRSP.

Enrollment

82 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Overtly healthy female subjects, as determined by medical history, physical examination including breast examination, gynecological examination (including cervical smear [Pap smear]), vital signs, ECG, echocardiogram, and laboratory tests.
Negative pregnancy test at subject screening.
Women who ovulate in the Pre-Treatment Cycle.
Willing to use a non-hormonal method of contraception (e.g. condom) during the wash-out period, Pre-Treatment Cycle and Post-Treatment Cycle.
BMI between 18.0 and 35.0 kg/m², inclusive, at time of Screening.
Able to fulfill the requirements of the protocol and have indicated a willingness to participate in the study by providing written informed consent form (ICF).

Exclusion criteria

Irregular menstrual cycle.
Amenorrhea or abnormal uterine bleeding.
Clinically relevant abnormal laboratory result at Screening.
Clinically significant abnormalities of the uterus and/or ovaries detected by examination and/or ultrasound.
Known hypersensitivity to any of the investigational or reference product ingredients.
Intention to become pregnant during the course of the study.
Pregnancy during accurate hormonal contraceptive use in the past.
Dyslipoproteinemia requiring active treatment with antilipidemic agent.
Diabetes mellitus with vascular involvement (nephropathy, retinopathy, neuropathy, other) or diabetes mellitus of more than 20-year duration.
Any arterial hypertension.
Any condition associated with an increased risk of venous thromboembolism and/or arterial thromboembolism.
Complicated valvular heart disease.
History of pregnancy-related cardiomyopathy or moderately or severely impaired cardiac function.
Systemic lupus erythematosus.
Presence or history of migraine with aura.
Abnormal Papanicolaou (PAP) smear result.
Presence of an undiagnosed breast mass.
Current symptomatic gallbladder disease.
History of COC-related cholestasis.
Presence or history of severe hepatic disease.
Presence or history of pancreatitis if associated with hypertriglyceridemia.
Porphyria.
Presence or history of hepatocellular adenoma or malignant liver tumors.
Renal impairment.
Hyperkaliemia or presence of conditions that predispose to hyperkaliemia.
Presence or history of hormone-related malignancy.
History of non-hormone-related malignancy within 5 years before Screening. Subjects with a non-melanoma skin cancer are allowed in the study.
Use of drugs potentially triggering interactions with COCs.
History of alcohol or drug abuse.
Any prior procedure, disease or condition that could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the investigational product.
Uncontrolled thyroid disorders.
Have received an investigational drug within the last 2 cycles prior to start of Pre-Treatment Cycle. Subjects who participated in an oral contraceptive clinical study, using Food and Drug Administration (FDA)/European Union (EU) approved active ingredients, may start the Pre-Treatment Cycle one cycle after last medication intake of the preceding study.
Sponsor, contract research organization (CRO) or PI's site personnel directly affiliated with this study.
Is judged by the PI to be unsuitable for any reason.