E4/DRSP Ovarian Function Inhibition Study

• Status: Completed
• Trial end date: 2018-06-08
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Estetra
• Treatments: Drospirenone; Ethinyl Estradiol

Criteria

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.