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Trial record 10 of 53 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND containing

E4/DRSP Ovarian Function Inhibition Study

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ClinicalTrials.gov Identifier: NCT03091595
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Estetra

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.

Condition or disease Intervention/treatment Phase
Prevention of Pregnancy Drug: 15 mg E4/3 mg DRSP Drug: 20 mcg EE/3 mg DRSP Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Single-center, Randomized, Open-label, Two-arm Study to Evaluate the Ovarian Function Inhibition of a Monophasic Combined Oral Contraceptive (COC) Containing 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP) and a Monophasic COC Containing 20mcg Ethinylestradiol (EE)/3 mg DRSP (YAZ®), Administered Orally Once Daily in a 24/4 Day Regimen for Three Consecutive Cycles
Actual Study Start Date : February 7, 2017
Actual Primary Completion Date : June 8, 2018
Actual Study Completion Date : June 8, 2018

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Arm Intervention/treatment
Experimental: 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.
Drug: 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
Other Name: 15 mg estetrol combined with 3 mg drospirenone

Active Comparator: 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.
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
Other Name: 20 mcg ethinylestradiol combined with 3 mg drospirenone (Yaz)




Primary Outcome Measures :
  1. Proportion of subjects with ovarian inhibition at treatment Cycle 1 [ Time Frame: All assessments will be performed once every 3 days starting treatment Cycle 1 Day 3 (± 1 day) until Day 27 (± 1 day) (one treatment cycle = 28 days). ]

    Ovarian inhibition will be assessed by rating the suppression of ovaries using the Hoogland score. This score is based on:

    • the follicular size assessed by transvaginal ultrasound (TVUS)
    • endogenous hormone levels: serum E2, and serum progesterone.

  2. Proportion of subjects with ovarian inhibition at treatment Cycle 3 [ Time Frame: All assessments will be performed once every 3 days starting treatment Cycle 3 Day 3 (± 1 day) until Day 27 (± 1 day) (one treatment cycle = 28 days). ]

    Ovarian inhibition will be assessed by rating the suppression of ovaries using the Hoogland score. This score is based on:

    • the follicular size assessed by TVUS
    • endogenous hormone levels: serum E2, and serum progesterone.


Secondary Outcome Measures :
  1. Serum level of luteinizing hormone (LH) [ Time Frame: On cycle Day 3, 6, 9, 12, 15, 18, 21, 24, 27 at treatment Cycle 1 and treatment Cycle 3 and on cycle Day 3 of the Treatment Cycle 2 ]
    Blood samples will be taken at regular time points defined in the time frame.

  2. Serum level of follicle stimulating hormone (FSH) [ Time Frame: On cycle Day 3, 6, 9, 12, 15, 18, 21, 24, 27 at treatment Cycle 1 and treatment Cycle 3 and on cycle Day 3 of the Treatment Cycle 2 ]
    Blood samples will be taken at regular time points defined in the time frame.

  3. Serum level of estradiol (E2) [ Time Frame: On cycle Day 3, 6, 9, 12, 15, 18, 21, 24, 27 at treatment Cycle 1 and treatment Cycle 3 and on cycle Day 3 of the Treatment Cycle 2 ]
    Blood samples will be taken at regular time points defined in the time frame.

  4. Serum level of progesterone (P) [ Time Frame: On cycle Day 3, 6, 9, 12, 15, 18, 21, 24, 27 at treatment Cycle 1 and treatment Cycle 3 and on cycle Day 3 of the Treatment Cycle 2 ]
    Blood samples will be taken at regular time points defined in the time frame.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091595


Locations
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Netherlands
Dinox BV
Groningen, Netherlands, 9713 CZ
Sponsors and Collaborators
Estetra
Investigators
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Principal Investigator: Christine Klipping Dinox BV

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Responsible Party: Estetra
ClinicalTrials.gov Identifier: NCT03091595     History of Changes
Other Study ID Numbers: MIT-Es0001-C202
2016-004267-40 ( EudraCT Number )
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Drospirenone
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents