A Study to Evaluate the Effect of a Contraceptive Vaginal Ring LSP-5415 Releasing Ethinyl Estradiol plus Etonogestrel on Ovarian Function in Healthy Adult Females
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- The proportion of subjects in Cohort 1 with complete ovarian inhibition over the entire treatment period (3 treatment cycles). Ovarian inhibition will be assessed by rating the suppression of ovaries using the Hoogland score (Hoogland HJ, Skouby SO, 1993). This score is based on The follicular size assessed by transvaginal ultrasound (TVUS).
研究概览
简要总结
Lupin is developing LSP-5415, a contraceptive vaginal ring (CVR) containing etonogestrel (ENG) and ethinyl estradiol (EE), intended for continual contraceptive delivery over a 28-day menstrual cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Must be able to read and write and willing to sign Informed Consent Form prior to study participation in accordance with legal requirements. 2.Females (18 to 35 years of age, inclusive) without uncontrolled concomitant disease at the Baseline Visit. 3.Have a regular menstrual cycle that is 24-32 days in duration. 4.Cohort #
- •BMI of 18 kg/m2 to 30 kg/m2, inclusive. Cohort #
- •BMI > 30 kg/m2 to ≤ 35 kg/m
- •5.Will not be at risk for pregnancy; subjects must agree to consistently use reliable non-hormonal contraceptive methods (spermicide-coated condoms, sterilization, male partner’s sterilization via vasectomy, or sexual abstinence), or be in a same-sex relationship from screening through study completion or be surgically sterilized by bilateral tubal ligation. 6.Both ovaries and uterus must be intact, and visible on transvaginal ultrasound (TVUS) examination during screening. 7.Subjects must be in good physical and mental health as determined by vital signs, medical history and clinical examination. 8.Subjects must have a blood pressure reading in a sitting position, between 90-140 mmHg (systolic) and 50-90 mmHg (diastolic) and pulse rate between 50 and 100 bpm. 9.Be at least 3 months after a delivery or abortion. 10.Be at least six months since last progestin injection with one or more spontaneous menses. 11.Willing to abstain from vaginal products e.g., tampons, intravaginal medications etc. during the ring wear period for the study duration except water based vaginal lubricants/spermicides.
排除标准
- •Pregnancy, a positive serum β-hCG pregnancy test at screening or lactation.
- •2.Use of tobacco- or nicotine-containing products within 6 months prior to study drug administration on Day 1 of treatment cycle
- •3.Have a history of cervical carcinoma or other carcinomas of the vagina or vulva.
- •Subjects 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.
- •Subjects 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.
- •6.History of thrombophlebitis, venous or arterial thromboembolic diseases.
- •7.Any known severe neurological, gastrointestinal, hepatic or other disease that might interfere with the intake of an investigational drug or any study condition.
- •8.Planned surgical procedures during the study period.
- •9.Clinically relevant/significant findings from serum biochemistry and hematology and HBsAg and C Virus/HlV serology as evaluated by the investigator.
- •10.Clinically relevant electrocardiogram findings.
- •11.An ovulatory pre-treatment cycle, or no ovulation by Day 27 of the pre-treatment cycle, or sonographical peculiarities concerning the ovarian status, that have not disappeared during the pre-treatment cycle.
- •12.Ovarian cyst larger than 3 cm in largest dimension on TVUS that persists during the pre-treatment ovulatory cycle.
- •13.Additional contraindications related to the use of ethinyl estradiol, or hormonal contraceptives including women with a high risk of arterial or venous thrombotic diseases.
- •Examples include women who are known to: Have cerebrovascular, coronary artery, thrombogenic valvular or thrombogenic rhythm, inherited or acquired hypercoagulopathies, Have uncontrolled hypertension, diabetes mellitus, headaches with focal neurological symptoms or migraine headaches with aura 14.History of migraine with focal neurological symptoms.
- •15.Known hereditary or acquired predisposition for venous and/or arterial thromboembolism.
- •16.Less than 2 weeks remobilization after major surgery or prolonged immobilization.
- •17.Alcohol, drug, or medicine abuse, or suspicion thereof.
- •18.Known allergy to any ingredient of the investigational drug.
- •19.Use of long-acting injectable or implant hormonal therapy.
- •A washout period of 10 months and two regular cycles is required after use of long-acting injectable contraceptive therapy or implant hormonal therapy prior to the pre-treatment cycle.
- •20.Use of hormonal or non-hormonal Intrauterine devices within 30 days prior to the start of the pre-treatment cycle.
- •21.Participation in another clinical trial at same time or within the preceding three months.
- •22.Subjects with a desire to become pregnant during the study.
- •23.Undiagnosed vaginal discharge, vaginal lesions/abnormalities or undiagnosed abnormal uterine bleeding.
- •Subjects suspected of having a vaginal infection may be enrolled after treatment and subsequent negative test results; partner treatment is also recommended.
结局指标
主要结局
The proportion of subjects in Cohort 1 with complete ovarian inhibition over the entire treatment period (3 treatment cycles). Ovarian inhibition will be assessed by rating the suppression of ovaries using the Hoogland score (Hoogland HJ, Skouby SO, 1993). This score is based on The follicular size assessed by transvaginal ultrasound (TVUS).
时间窗: Cycle1 Predose,1,2,6,8hrs on Day1,4,6,8,12,14,18,22,26,27, 6hrs post-removal and Day28. Cycle2 Predose, 4 hrs on Day1,4,8,14,22,26,27, 6 hrs post-removal and Day28 (24hrs postremoval). Cycle3 Predose,1,2,6,8hrs on Day1, 4, 6, 8, 12, 14, 18, 22, 26, 27, 6hrs postremoval,Day28(24hrs postremoval) and 29 (48hrs postremoval). For SHBG will be collected pre-insertion on Cycle1, Day1 and pre-removal on Cycle3, Day27.
A Hoogland and Skouby grade 3 and below represents ovulation inhibition.
时间窗: Cycle1 Predose,1,2,6,8hrs on Day1,4,6,8,12,14,18,22,26,27, 6hrs post-removal and Day28. Cycle2 Predose, 4 hrs on Day1,4,8,14,22,26,27, 6 hrs post-removal and Day28 (24hrs postremoval). Cycle3 Predose,1,2,6,8hrs on Day1, 4, 6, 8, 12, 14, 18, 22, 26, 27, 6hrs postremoval,Day28(24hrs postremoval) and 29 (48hrs postremoval). For SHBG will be collected pre-insertion on Cycle1, Day1 and pre-removal on Cycle3, Day27.
Endogenous hormone levels: serum Estradiol (E2), and serum Progesterone (P).
时间窗: Cycle1 Predose,1,2,6,8hrs on Day1,4,6,8,12,14,18,22,26,27, 6hrs post-removal and Day28. Cycle2 Predose, 4 hrs on Day1,4,8,14,22,26,27, 6 hrs post-removal and Day28 (24hrs postremoval). Cycle3 Predose,1,2,6,8hrs on Day1, 4, 6, 8, 12, 14, 18, 22, 26, 27, 6hrs postremoval,Day28(24hrs postremoval) and 29 (48hrs postremoval). For SHBG will be collected pre-insertion on Cycle1, Day1 and pre-removal on Cycle3, Day27.
次要结局
- Serum level of Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), E2, P. -Plasma levels of EE, ENG: blood samples will be taken at regular time points during Cycle 1, 2 and 3 (26-day wear period).-Samples for sex hormone-binding globulin (SHBG) will be collected pre-insertion on Cycle 1, Day 1 and pre-removal on Cycle 3, Day 27.-Safety parameters including adverse events, clinical laboratory parameters, and vital sign measurements.