E4/DRSP Ovarian Function Inhibition Study

NCT ID: NCT03091595

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-07
• Study Completion Date: 2018-06-08

Brief 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.

Conditions

Prevention of Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

15 mg E4/3 mg DRSP

15 mg E4 combined with 3 mg DRSP administered in a 24/4-day regimen. One tablet per day orally for 3 treatment cycles.

Group Type: EXPERIMENTAL

15 mg E4/3 mg DRSP

Intervention Type: DRUG

15 mg E4/3 mg DRSP combined tablets will be administered orally once daily in a 24/4 day regimen for three consecutive cycles

20 mcg EE/3 mg DRSP

20 mcg EE combined with 3 mg DRSP administered in a 24/4-day regimen. One tablet per day orally for 3 treatment cycles.

Group Type: ACTIVE_COMPARATOR

20 mcg EE/3 mg DRSP

Intervention Type: DRUG

20 mcg EE/3 mg DRSP combined tablets will be administered orally once daily in a 24/4 day regimen for three consecutive cycles

Interventions

15 mg E4/3 mg DRSP

15 mg E4/3 mg DRSP combined tablets will be administered orally once daily in a 24/4 day regimen for three consecutive cycles

Intervention Type: DRUG

20 mcg EE/3 mg DRSP

20 mcg EE/3 mg DRSP combined tablets will be administered orally once daily in a 24/4 day regimen for three consecutive cycles

Intervention Type: DRUG

Other Intervention Names

15 mg estetrol combined with 3 mg drospirenone; 20 mcg ethinylestradiol combined with 3 mg drospirenone (Yaz)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Estetra

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Klipping

Role: PRINCIPAL_INVESTIGATOR

Dinox BV

Locations

Dinox BV

Groningen, , Netherlands

Countries

Netherlands

Related Links

https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-004267-40/results

Trial results were released to public view on the EudraCT (EudraCT Number: 2016-004267-40).

Other Identifiers

2016-004267-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MIT-Es0001-C202

Identifier Type: -

Identifier Source: org_study_id