CTRI/2024/08/072277Other (Terminated)不适用
A Multi-Center, Open-Label, Randomized, Single Dose, Parallel Design, In Vivo/Ex Vivo Pharmacokinetic study of LSP-9759 (etonogestrel implant, 68 mg) and Nexplanon®, etonogestrel implant, 68 mg in Healthy Female Participants
Loop Therapeutics LLC5 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2025年10月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- Other (Terminated)
- 发起方
- 入组人数
- 310
- 试验地点
- 5
- 主要终点
- The primary objective of this parallel study is to demonstrate bioequivalence between LSP-9759 (etonogestrel implant, 68 mg, Loop Therapeutics, LLC) and Nexplanon®, etonogestrel implant, 68 mg (Organon Global Inc.) at 26 weeks after implantation.
研究概览
简要总结
This is an open-label, randomized parallel design, in vivo/ex vivo, bioequivalence study in healthy, premenopausal adult female participants.
Up to 310 adult female healthy participants will be randomized (1:1) to receive either LSP-9759 or Nexplanon® to achieve 222 completed participants. After 26 weeks of treatment the implant will be removed and residual amount of etonogestrel will be assessed.
Participants who meet all study inclusion and no study exclusion criteria will be randomized to receive either LSP-9759 or Nexplanon on Study Day 1. The randomization will be stratified by site and participant BMI (<20.0, 20.0-24.9, ≥25.0 kg/m2) based on participant’s Day -1 weight.
At time of implantation, the participant must be between Day 1 (first day of menstrual bleeding) and Day 5 of the menstrual cycle, even if the participant is still bleeding.
Participants will be admitted to the clinic on Study Day -1 and will remain in the clinical for at least 72 hours after implantation of the study drug to allow for safety monitoring and PK sample collection.
Participants will also return for a total of 12 outpatient visits for safety monitoring and PK sample collection and on Study Day 183 for safety monitoring, PK sample collection and removal of the study drug implant.
A total of 21 pharmacokinetic samples (7.0 mL each) will be collected from each participant.
Pharmacokinetic samples will be taken at Pre-Dose (up to 2 hours prior to implantation) and at 2, 4, 6, 8, 12, 24 (Study Day 2), 48 (Study Day 3), 72 (Study Day 4), 96 (Study Day 5), 120 (Study Day 6), 168 (Study Day 8), 240 (Study Day 11), 336 (Study Day 15), 504 (Study Day 22), 672 (Study Day 29), 1344 (Study Day 57), 2016 (Study Day 85), 2688 (Study Day 113), 3360 (Study Day 141) and 4368 (Study Day 183) hours post dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Must be able, and willing, to give written Informed Consent prior to study participation in accordance with legal requirements and in a language that the participant understands.
- •Healthy, premenopausal, nonpregnant females, ages 18 to 45 years (inclusive), who are not using other hormonal contraceptive methods.
- •Have a regular menstrual cycle (
- •35 day cycles) without hormonal contraceptive use and at time of planned implantation (Study Day 1) be on Days 1-5 of menstrual cycle.
- •Body Mass Index (BMI) of 18.5 kg/m2 to 30.0 kg/m2, and weight ≥45 kg.
- •Participants must be in good physical and mental health as determined by vital signs, clinical laboratory testing, physical examination, breast examination, and medical history.
- •Participants must have a negative chlamydia and gonorrhea test at Screening.
- •If heterosexually active, WOCBP must agree to use contraception considered medically adequate and appropriate throughout the course of the study and for 1 month after the removal of the implant. Acceptable contraception methods are: a. Vasectomized partner (at least 6 months before enrollment) b. Double barrier method (e.g., diaphragm with spermicide; condoms with spermicide) c. Abstinence (must agree to use a double barrier method if they become sexually active during the study).
排除标准
- •Postmenopausal females.
- •Weight greater than 130% of ideal body weight.
- •Pregnancy, a positive pregnancy test at Screening or Study Day -1 or lactation, or plans to become pregnant during the study.
- •Vaginal delivery, cesarean delivery, or abortion within six weeks prior to implantation.
- •Known or suspected uterine or cervical neoplasia, now or in the past.
- •Known or suspected breast cancer or other progestin-sensitive cancer, now or in the past.
- •Undiagnosed vaginal discharge or undiagnosed/abnormal uterine bleeding.
- •Participants with abnormal pap smears that require colposcopic evaluations as defined by the Fourth American Society of Colposcopy and Cervical Pathology (ASCCP) sponsored guidelines for management of cervical cancer abnormalities during the next 6 months are excluded.
- •Participants with abnormal pap smear and who have undergone colposcopic evaluation which has determined that a cervical procedure is not necessary during the 6 months following the colposcopy are allowed.
- •Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections.
- •Past or present history of acute liver disease or liver tumor (benign or malignant).
- •A previously inserted intrauterine device (hormonal or non-hormonal) that has not been removed within 8 weeks prior to Study Day
- •Use of long-acting injectable contraceptive (depo-medroxyprogesterone) with a dose given within six months prior to Study Day 1 and at least 2 menstrual periods prior to Study Day
- •Prior implanted contraception with removal less than 3 months prior to Study Day
- •Prior use of oral contraceptives within 1 month to Study Day
- •History or evidence of any clinically significant (as determined by the investigator) cardiovascular (including hypertension), gastrointestinal, endocrine, gynecologic, ophthalmologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary (including asthma or emphysema), neurologic, dermatologic, psychiatric (including depression), renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer).
- •Clinically significant findings from clinical laboratory tests at screening.
- •Participant has a positive test for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) or syphilis (VDRL) at screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection.
- •Clinically significant electrocardiogram (ECG) findings or QTcF greater than 450 msec at Screening.
- •Participant has a known hypersensitivity reaction or contraindication to progesterone or any components of the formulation.
- •History of thrombophlebitis, venous or arterial thromboembolic diseases (thrombosis, pulmonary embolism, stroke or myocardial infarction).
- •History of surgery to the veins or arteries of the lower extremities or findings on physical exam such as presence of significant varicosities and peripheral edema.
- •Past, present, family history, known hereditary or acquired predisposition for venous and/or arterial thromboembolism (e.g., activated protein C (APC) resistance, anti-cardiolipin antibodies, or coagulopathy).
- •Participants at increased risk for infectious endocarditis (e.g., prosthetic heart valves, rheumatic heart disease, previous endocarditis).
- •History of migraine with focal neurological symptoms.
- •Less than 4 weeks remobilization after major surgery or prolonged immobilization.
- •Alcohol, drug, or medicine (prescription or recreational) abuse, or suspicion thereof or the participant tests positive at screening or Study Day -1 for alcohol or drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates).
- •Participant is a current smoker, nicotine, or tobacco user in any form or has used nicotine or tobacco containing products within the past 6 months.
- •Participant has used prescription or non-prescription drugs including herbal and iron supplements within 2 weeks or 5 half-lives (whichever is longer) prior to enrollment (excluding paracetamol/acetaminophen (≤ 3 grams per day), ibuprofen (≤ 1200 mg/day), naproxen sodium (≤ 660 mg/day) and levocetirizine (≤ 5mg/day)).
- •Participation in another clinical trial at the same time or within the preceding three months or has received an investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening.
- •Participant has a sitting mean systolic blood pressure less than 90 or greater than 140 mmHg and a mean diastolic blood pressure less than 50 or greater than 90 mmHg, or pulse rate higher than 100 beats per min (bpm), either at screening or clinic check in (measurements taken in duplicate after participant has been resting in a sitting position for a minimum of 5 minutes).
- •Participant had a significant blood loss or donated one unit (450 mL) of blood within 60 days or donated plasma or platelets (one unit) within 30 days prior to Study Day
- •Participant has a history of allergic conditions or anaphylactic reactions including drug allergies (excluding untreated seasonal allergies or seasonal allergies treated by antihistamines).
- •Participant has any other condition, which in the opinion of the Investigator, precludes the participant’s participation in the study or the participant is unlikely to comply with the protocol-defined procedures or complete the study.
结局指标
主要结局
The primary objective of this parallel study is to demonstrate bioequivalence between LSP-9759 (etonogestrel implant, 68 mg, Loop Therapeutics, LLC) and Nexplanon®, etonogestrel implant, 68 mg (Organon Global Inc.) at 26 weeks after implantation.
时间窗: Day 1 to Day 183 (or ET)
次要结局
- The safety objective is to assess the safety & tolerability of LSP-9759 & Nexplanon® in healthy adult female participants.(26 weeks)
研究者
Dr Dharmesh Domadia
Cliantha Research limited
研究点 (5)
Loading locations...
相似试验
招募中
1 期
Bioequivalence Study of GZR18 Injection Before and After CMC ChangeNCT07355738Gan & Lee Pharmaceuticals.138
已完成
不适用
A Single Dose Two Period Study Comparing Cabozantinib 60 mg Tablets In Healthy Adult Human Subjects Under Fasting ConditionsCTRI/2025/08/092950BDR pharmaceuticals International Pvt Ltd18
已完成
不适用
An Open Label Single Dose Two Treatment Partial Replicate Reference Scaled Average Oral Bioequivalence Study Comparing Loratadine 1 mg/mL Oral Liquid Solutions 10 X 1 mg/mLCTRI/2024/12/077559Neo Health OTC Pty Ltd36
已完成
不适用
An Open Label Single Dose Two Treatment Three Period Partial Replicate Reference scaled Oral Bioequivalence Study Comparing Valsartan and Hydrochlorothiazide Tablets In Healthy Adult Human Subjects Under Fasting ConditionsCTRI/2025/02/081390Incepta Pharmaceuticals Ltd60
尚未招募
不适用
A Single Dose Four Period Study Comparing Diclofenac Tablet 100 mg In Healthy Adult Human Subjects Under Fasting ConditionsCTRI/2025/08/093013Unique Pharmaceutical Laboratories36