2026-526788-39-00招募中2 期
A single-centre, Phase 2, open-label study to investigate ovulation inhibition after the administration of different dosages of dienogest tablets in combination with different dosages of drospirenone tablets with regular intake and after intentional intake errors in healthy premenopausal female participants
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Ovulation incidence in treatment cycles 1-3. Ovulation is defined as Hoogland-Skouby score (HSS) 5 or 6.
研究概览
简要总结
To investigate ovulation inhibition during treatments with different dosages of dienogest in combination with different dosages of drospirenone with regular intake and after intentional 24-hour intake errors
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participant must be 18 to 35 years of age inclusive, at the time of signing the informed consent.
- •Participants must consent to use reliable non-hormonal contraceptive methods (male condoms, diaphragm, or heterosexual abstinence) throughout the study, unless the participant has a history of female sterilization or sterilization of the male sexual partner.
- •Participants must consent to refrain from participating in another clinical study and from blood or plasma donation during the course of the study.
- •Participants who are healthy post-menarcheal and premenopausal females.
- •Participants must be in good physical and mental health as determined by vital signs, medical history, clinical laboratory values and physical and gynaecological examination, as assessed by the investigator.
- •BMI not less than 18.0 kg/m2 at screening and P20 examination.
- •Capable of giving signed informed consent as described in Appendix 1, after having been informed about benefits and potential risks of the study, as well as details of the insurance taken out to cover the participant participating in the clinical trial.
- •Status at least 3 months after a delivery, abortion, and stopping lactation, if applicable, before screening.
- •Regular menstrual cycles that are between 21 and 35 days in duration as reported by the participant during anamnesis, with an intact uterus and ovaries. If the participant uses hormonal birth control at screening, historic data should be used to evaluate this criterion.
- •Both ovaries must be visible on TVUS examination during screening visit.
- •Ovulatory pre-treatment cycle, as confirmed by a progesterone concentration >10.0 nmol/L.
排除标准
- •Presence of any known severe systemic disease that might interfere with the conduct of the study or the interpretation of the results according to the judgement of the investigator.
- •Participants with inadequately controlled thyroid dysfunction. Participants with treated thyroid dysfunction with normal TSH levels may be included according to the investigator’s judgement.
- •Known diabetes mellitus.
- •Known severe disturbances of lipid metabolism.
- •Presence or history of known or suspected malignant or premalignant diseases.
- •Abnormal, clinically significant findings which, according to the assessment of the investigator, may worsen under hormonal treatment (e.g., pemphigoid gestations during a previous pregnancy, middle-ear deafness [otosclerosis]; Sydenham’s chorea, porphyria, systemic lupus erythematosus, haemolytic-uremic syndrome, hereditary angioedema).
- •Known hypersensitivity to any ingredients of the study medication (active ingredients or the constituents of the pharmaceutical preparations), including participants with rare hereditary problems or galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, or participants with severe allergies or multiple drug allergies unless deemed not clinically relevant by the investigator.
- •Other diseases: known osteopenia, osteoporosis, or any condition with decreased bone mineral density or bone metabolic disorder; migraine with neurologic symptoms (complicated migraine); undiagnosed vaginal bleeding, or any abnormal bleeding that is expected to recur during the study; worsening of epilepsy or chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) under hormonal treatment.
- •Major surgery or prolonged immobilization scheduled in the study period or within 14 days prior to screening. Minor surgical procedures (e.g., day case surgery) are permissible, as judged by the investigator.
- •Treatment with any systemic medication within 14 days or 5 half-lives of the given medication (whichever is longer) prior to the start of the pre-treatment cycle, which might interfere with the pharmacodynamics, pharmacokinetics or safety of the study interventions, including strong or moderate cytochrome P450 (CYP) 3A4 inhibitors and strong or moderate CYP3A4 inducers.
- •Treatment with GLP-1 receptor agonists or GIP receptor agonists within 14 days prior to the start of the pre-treatment cycle.
- •Presence of diseases or pathological findings of genital organs, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the study interventions according to the judgement of the investigator, e.g., clinically significant leiomyoma, endometriosis, or endometrial hyperplasia.
- •Presence or use of: a. a non-hormonal intrauterine contraceptive device (e.g., copper IUD), unless removed prior to screening. b. hormonal contraception preceding the pre-treatment cycle as follows: o Shortly acting hormonal contraceptives as oral, patch, ring or intrauterine system within one cycle. In this case, a washout cycle should be initiated, and the participant might restart the pre-treatment cycle in the next cycle. o Injectable (intramuscular or subcutaneous) within 10 months (three-month treatment duration), 6 months (two-month treatment duration) or 3 months (one-month treatment duration) prior to screening. o In case of washout phase, if no spontaneous menses started within 46 days after stop of short-acting hormonal contraceptive (last active treatment).
- •Participation in another clinical study or administration of any investigational medicinal product within 1 cycle or 5 half-lives of the given medication (whichever is longer) prior to start of the pre-treatment cycle. In this case, a washout cycle should be initiated, and the participant might restart the pre-treatment cycle in the next cycle.
- •Positive pregnancy test at screening examination.
- •Vital signs (measured after at least 5 minutes of resting) outside of the following ranges at screening examination: o Systolic blood pressure <90 or >139 mmHg; o Diastolic blood pressure <60 or >89 mmHg; o Pulse rate <50 bpm or >90 bpm. Two repeated measurement is allowed, the participant might be enrolled if the repeated measurement is within the given range.
- •Clinical laboratory values out of normal range at screening unless a minor deviation from normal is judged as not relevant for the clinical trial by the investigator.
- •Hyperkalaemia or presence of conditions that predispose to hyperkalaemia such as renal impairment, hepatic impairment, adrenal insufficiency and women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium concentration, as judged by the investigator (e.g., angiotensin-converting enzyme [ACE] inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists and non-steroidal anti-inflammatory drugs [NSAIDs]).
- •ASAT >120 % ULN, ALAT >110 % ULN, bilirubin >120% ULN (except in case of existing Morbus Gilbert-Meulengracht deduced from medical history) and creatinine > 0.1 mg/dL above ULN (limit of > 0.1 mg/dL corresponds to > 9 µmol/l).
- •Positive anti-HIV-test (if positive, to be verified by western blot), HBs-AG-test or anti-HCV-test.
- •Diagnosis of latest PAP smear: findings classified higher than score II-a (Munich Nomenclature III) within the last 12 months prior to screening.
- •Positive urine drug screen (UDS) at screening, except women with a positive UDS for opiates due to consumption of poppy seed, alcohol or nicotine; in case of a positive UDS, potential alcohol or opiate abuse should be judged by the investigator. For positive cotinine test, see exclusion criterion
- •Presence of cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the study interventions (e.g. valvular heart disease, atrial fibrillation, cardiac dysfunction NYHA I-IV, sickle cell anaemia, etc.).
- •Obese individuals (BMI ≥30 kg/m2) who use tobacco and/or nicotine containing products (including e-cigarettes) within 3 months of screening, as determined by positive cotinine test at screening.
- •History of or diagnosed with excessive alcohol use (see in Section 5.3.2 of the CTP) or drug abuse.
- •Participants suspected or known not to follow instructions.
- •Participants who are unable to understand the written and verbal instructions, particularly regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial.
- •Participant is a dependent person, e.g., a relative, family member, or member of the investigator’s staff.
- •Participants who are in custody by order of an authority or a court of law.
- •Participants, who actually desire to be pregnant during the course of the study.
- •Participants who are on a diet which could affect the pharmacokinetics of the active ingredients.
- •Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the participant’s safety.
- •Presence of hepatic and/or renal diseases or pathological diagnostic or laboratory findings, which might interfere with the safety, tolerability, or pharmacokinetics of the study interventions as judged by the investigator (e.g., any acute or chronic hepatic disease, disturbances of bilirubin metabolism, bile excretion, bile flow, icterus, presence or history of liver tumors (benign or malignant), gallstones or gallbladder disease, or other condition or disease resulting in impaired hepatic or renal function).
- •Presence of gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the study interventions.
- •Presence or history of pancreatitis.
- •History of relevant CNS and/or psychiatric disorders and/or currently treated relevant CNS and/or psychiatric disorders (e.g., clinically significant depression [current or within 12 months prior to screening]).
- •Presence or history of venous or arterial thromboembolic diseases (e.g., deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke), prodromal conditions (e.g., transient ischemic attack, angina pectoris) or cerebrovascular accident.
- •Presence of any known hereditary or acquired predisposition for venous or arterial thrombosis (e.g., Factor II or V [Leiden] mutations, APC-resistance, Antithrombin III deficiency, Protein-C and/or Protein-S deficiency, hyperhomocysteinaemia and antiphospholipid-antibodies), or anamnestic hints for increased risk of thrombosis events in family history (e.g., any venous thromboembolic event that occurred in a close relative at a young age [≤ 50 years]).
结局指标
主要结局
Ovulation incidence in treatment cycles 1-3. Ovulation is defined as Hoogland-Skouby score (HSS) 5 or 6.
Ovulation incidence in treatment cycles 1-3. Ovulation is defined as Hoogland-Skouby score (HSS) 5 or 6.
次要结局
- Ovulation incidence over treatment cycles 1, 2 and 3. Ovulation is defined as Hoogland-Skouby score (HSS) 5 or 6.
- Ovulation incidence over treatment cycles 1-2. Ovulation is defined as Hoogland-Skouby score (HSS) 5 or 6.
- • Hoogland-Skouby score determined over each treatment cycle • Participant-wise maximum Hoogland-Skouby score over treatment cycles 1-2 and over treatment cycles 1-3
- Fulfilment of Landgren criterion in cycles with Hoogland-Skouby score 5 or 6
- • FLS diameter and endometrial thickness determined by transvaginal ultrasound (TVUS) at each time point during treatment • Participant-wise maximum value of the FLS diameter and maximum endometrial thickness per treatment cycle, over treatment cycles 1-2 and over treatment cycles 1-3
- • Serum concentrations of estradiol (E2) and progesterone (P) at each time point during treatment • Participant-wise maximum concentrations of E2 and P per treatment cycle, over treatment cycles 1-2 and over treatment cycles 1-3 • Participant-wise mean concentrations of E2 per treatment cycle, over treatment cycles 1-2 and over treatment cycles 1-3 • Treatment group-wise mean and median concentrations of E2 and P per treatment cycle, over treatment cycles 1-2 and over treatment cycles 1-3
- • Plasma conc. of DNG & DRSP det. (sparse PK sampl. indep. of tab. intake time) • Trough plasma conc. of DNG & DRSP, for which blood samples are taken as follows: o on one visit during TC 1 (after D6) & on one visit during TC 2; 24 ± 1.5h after the last tab. intake & within 5 min. before the current tablet intake o on det. days during TC 3, 24 ± 1.5h after the last tab. intake o on det. days during TC 3, 48 ± 1.5h after the last tab. intake & within 5 min. before the sched. double dose intake
- • Tot. no. of bleed./spot. eps. in TC 1-3 • Tot. no. of days of bleed./spot., bleed. only & spot. only in TC 1-3, TC 1-2, TC 1, 2 & 3 • Prop. of wmn with bleed./spot., bleed. only, spot. only in TC 1-3 (excl. the first 7 TD) • Prop. of wmn with bleed./spot., bleed. only, spot. only in TC 1-2 (excl. the first 7 TD) • Prop. of wmn with bleed./spot., bleed. only, spot. only per TC 1 (excl. the first 7 TD), 2 & 3 • Prop. of light, usual & heavy bleed. days per TC 1, 2 & 3
- • Adverse Events • Safety clinical laboratory parameters
研究者
Medical Information Scientific Service
Scientific
Gedeon Richter Plc.
研究点 (1)
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