CCTN - PHARMACOKINETIC / PHARMACODYNAMIC EVALUATION OF LEVONORGESTREL BUTANOATE FOR FEMALE CONTRACEPTION
CCTN - 丁酸左炔诺孕酮用于女性避孕的药代动力学/药效学评价
基本信息
- 批准号:10497855
- 负责人:
- 金额:$ 11.12万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2018
- 资助国家:美国
- 起止时间:2018-09-28 至 2023-09-27
- 项目状态:已结题
- 来源:
- 关键词:AdherenceAgeBody mass indexClinicalClinical Practice GuidelineClinical TrialsClinical Trials NetworkContraceptive AgentsContraceptive methodsContractorDataDevelopmentDoseDrug KineticsEnrollmentEstrogensEvaluationFemale Contraceptive AgentsFree WillGoalsGood Clinical PracticeGovernmentImplantInjectableInjectionsInternationalIntramuscularIntrauterine DevicesLactationLevonorgestrelMissionMonitorNational Institute of Child Health and Human DevelopmentNon obeseObesityPharmacodynamicsPopulationProgestinsProtocols documentationPublic HealthRecording of previous eventsRecordsRegimenRegulationRiskRouteSafetyTimeUnited States Food and Drug AdministrationWomancontraceptive efficacyfollow-uppillprotocol developmentrecruitreproductivesubcutaneoussymposiumvenous thromboembolism
项目摘要
There is a demand for estrogen-free contraception in order to reduce the risk of venous
thromboembolism (VTE), particularly for obese women. A new long-acting ormulation of
levonorgestrel butanoate (LB) delivered by injection has been developed. Levonorgestrel (LNG)
has a long history of clinical use in a variety of contraceptives (pills, intrauterine devices, and
implants) and its efficacy and safety are well recognized.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD) has a mission to develop safe and effective contraceptives for women, including obese
women. Obesity is the number one public health issue facing the US population and is an
independent risk for venous thromboembolism (VTE). Therefore, there is a public health need to
develop effective contraception for obese woman that does not increase the risk of VTE. One
Food and Drug Administration (FDA) -approved contraceptive method is the progestin-only pill
(POP) or so-called "mini pill," which is used mainly by lactating women only for several months
and requires strict adherence to taking the POP at the same time every day. A long-acting
injectable form of LB that is estrogen-free will provide a regimen that is easier to follow than a
POP and have a theoretically lower risk of VTE especially for obese women. In order to provide
preliminary evidence that LB could be effective for contraception, a clinical trial will be
conducted in the NICHD Contraceptive Clinical Trials Network (CCTN).
The proposed study will be conducted in women of reproductive age in order to evaluate
pharmacokinetics, the mechanisms of contraceptive efficacy, and safety of this new
contraceptive. The enrolled subjects will receive LB via intramuscular and subcutaneous routes of
injection. The Recruitment will include enrollment of approximately 50% of subjects with BMI
>=32 kg/m2 but less than 40 kg/m2
为了降低静脉性感染的风险,需要无雌激素避孕
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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CAROLYN L WESTHOFF其他文献
CAROLYN L WESTHOFF的其他文献
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{{ truncateString('CAROLYN L WESTHOFF', 18)}}的其他基金
CCTN - PHARMACOKINETIC / PHARMACODYNAMIC EVALUATION OF LEVONORGESTREL BUTANOATE FOR FEMALE CONTRACEPTION
CCTN - 丁酸左炔诺孕酮用于女性避孕的药代动力学/药效学评价
- 批准号:
10939295 - 财政年份:2018
- 资助金额:
$ 11.12万 - 项目类别:
CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - CORE - FEMALE
CCTN - 避孕临床试验网络 - 核心 - 女性
- 批准号:
9525758 - 财政年份:2017
- 资助金额:
$ 11.12万 - 项目类别:
A Prospective, Randomized Study to Compare Effects of Ulipristal Acetate with a Combined Oral Contraceptive on Breast Epithelial Cell Proliferation.
一项前瞻性随机研究,比较醋酸乌利司他与复方口服避孕药对乳腺上皮细胞增殖的影响。
- 批准号:
9006850 - 财政年份:2016
- 资助金额:
$ 11.12万 - 项目类别:
A Prospective, Randomized Study to Compare Effects of Ulipristal Acetate with a Combined Oral Contraceptive on Breast Epithelial Cell Proliferation.
一项前瞻性随机研究,比较醋酸乌利司他与复方口服避孕药对乳腺上皮细胞增殖的影响。
- 批准号:
9307756 - 财政年份:2016
- 资助金额:
$ 11.12万 - 项目类别:
CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - EVALUATION REVERSIBLE CONTRACEPTIVE
CCTN - 避孕临床试验网络 - 评估可逆避孕药
- 批准号:
9923499 - 财政年份:2015
- 资助金额:
$ 11.12万 - 项目类别:
CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - EVALUATION REVERSIBLE CONTRACEPTIVE
CCTN - 避孕临床试验网络 - 评估可逆避孕药
- 批准号:
9149743 - 财政年份:2015
- 资助金额:
$ 11.12万 - 项目类别:
CCTN - CLINICAL EVALUATION OF NOVEL PRODUCTS FOR FEMALE CONTRACEPTION: PILOT AND EFFICACY STUDY
CCTN - 女性避孕新产品的临床评价:试点和功效研究
- 批准号:
8933135 - 财政年份:2014
- 资助金额:
$ 11.12万 - 项目类别:
CCTN - CLINICAL EVALUATION OF NOVEL PRODUCTS FOR FEMALE CONTRACEPTION: PILOT AND EFFICACY STUDY
CCTN - 女性避孕新产品的临床评价:试点和功效研究
- 批准号:
10271385 - 财政年份:2014
- 资助金额:
$ 11.12万 - 项目类别:
CCTN - CLINICAL EVALUATION OF NOVEL PRODUCTS FOR FEMALE CONTRACEPTION: PILOT AND EFFICACY STUDY
CCTN - 女性避孕新产品的临床评价:试点和功效研究
- 批准号:
10421163 - 财政年份:2014
- 资助金额:
$ 11.12万 - 项目类别:
CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - CORE - FEMALE
CCTN - 避孕临床试验网络 - 核心 - 女性
- 批准号:
8887060 - 财政年份:2013
- 资助金额:
$ 11.12万 - 项目类别:
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