这是一项随机交叉研究,用于评估在皮下注射新型仓储麦德洛基酸避孕药配方后的局部耐受性
Vera Halpern1, Angie Wheeless1, Vivian Brache2
1FHI 360, Durham, NC, United States.
Contraception: X
|October 12, 2023
概括
这项研究比较了TV-46046和Depo-subQ Provera 104的局部耐受性. 虽然两次MPA注射都显示出最小的疼痛,但TV-46046的注射部位反应率更高,特别是低颜色.
科学领域:
- 药理学 药理学是指药理学的学科.
- 皮肤病学 皮肤病学
- 生殖健康 生殖健康
背景情况:
- 甲 (MPA) 在注射避孕药中使用.
- 皮下MPA配方的局部耐受性对于用户坚持使用至关重要.
- TV-46046是一种正在研究中的MPA药物,与Depo-subQ Provera 104.4进行比较.
研究的目的:
- 为了比较TV-46046和Depo-subQ Provera 104.4的局部耐受性.
- 评估注射部位反应 (ISR) 和与皮下MPA注射相关的疼痛.
- 评估TV-46046.6的整体安全情况.
主要方法:
- 一项随机,交叉,单中心研究,涉及27名健康女性.
- 参与者接受了TV-46046 (未稀释和稀释),TV-46046安慰剂和Depo-subQ Provera 104.4的皮下注射.
- 通过ISR,注射部位疼痛和9个月的安全监测来评估局部耐受性.
主要成果:
- 从105次全剂量注射中总共观察到30个ISR.
- 低颜色是最常见的ISR (24例),注射后平均发生8个月.
- 与Depo-subQ Provera 104 (26.9%) 相比,未稀释的TV-46046显示出更高的ISR率 (44.0%),尽管在统计学上并不显著.
结论:
- 皮下MPA悬浮剂与延迟的低颜色化有关.
- TV-46046证明了进一步临床测试作为6个月避孕药的适当安全性.
- 需要进一步调查TV-46046的低颜色和用户可接受性.
相关概念视频
Crossover Experiments
2.9K
Crossover experiments, also called the repeated-measurements design, is a study design in which all experimental units are exposed to all treatments in different periods. Crossover experiments are generally used in psychology, the pharmaceutical industry, agriculture, and medicine.
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.
2.9K
Dosage Regimen: Fixed Dose
1.9K
Fixed-dose regimens are a common approach to administer drugs to achieve and maintain desired levels of the drug in the body. In this dosing strategy, a specific amount of medication is given at regular intervals, often multiple times a day, to ensure a consistent drug concentration in the bloodstream.
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
1.9K
Bioequivalence: Overview
1.1K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
1.1K
Drug Delivery: Parenteral Route
580
The parenteral route is a critical method of drug administration. It delivers compounds directly into the systemic circulation and bypasses the gastrointestinal tract. This approach is particularly advantageous for drugs that exhibit poor absorption or instability when administered orally.
There are three primary parenteral routes: intravenous (IV), intramuscular (IM), and subcutaneous (SC). The IV route introduces the drug directly into the bloodstream, ensuring immediate action. The IM route...
There are three primary parenteral routes: intravenous (IV), intramuscular (IM), and subcutaneous (SC). The IV route introduces the drug directly into the bloodstream, ensuring immediate action. The IM route...
580
Birth Control Methods
298
Vasectomy is a surgical form of male sterilization that involves severing and sealing the vasa deferentia, preventing sperm from mixing with semen during ejaculation. Because a vasectomy does not impact the testes' ability to produce testosterone, hormone levels, libido, and sexual function generally remain unchanged. While vasectomy is highly effective in preventing pregnancy, with a success rate near 99.85%, rare cases of recanalization (spontaneous reconnection) can occur. Although...
298
Local Anesthetics: Pharmacokinetics
775
The potency and duration of action of local anesthetics (LAs) are determined by their pharmacokinetics. Pharmacokinetics describes how LAs are absorbed, distributed, metabolized, and eliminated from the body. When administered to the vascular tissues, LAs are quickly absorbed and enter the systemic circulation, reducing their localized effects. Adding vasoconstrictors such as epinephrine to LAs reduces their absorption into the systemic circulation, making them clinically effective. The...
775


