First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adverse events recorded from 400 mg progesterone Callavid
研究概览
简要总结
The aim of this clinical trial is to assess safety of a new vaginal 400mg progesterone drug-device combination product in a first in human trial. Additionally, it aims to assess user acceptability and ability to deliver progesterone. This Phase I trial is a randomised open-label first-in-human crossover trial, recruiting participants who are non-pregnant with luteal phase insufficiency. The main questions it aims to answer are:
- What are the safety and tolerability profiles of the two progesterone formulations (400mg Progesterone Callavid vs. Cyclogest 400 mg), including the incidence of adverse events (if any) such as allergic reactions, gastrointestinal symptoms (e.g. bloating, constipation), and neurological effects (e.g. headache, drowsiness, euphoria)?
- What is usability experience for patients using the Callavid drug-device combination compared to pessaries / suppositories (i.e. Cyclogest 400 mg)?
- How do serum progesterone levels vary within participants when using 400 mg progesterone delivered via the Callavid drug-device combination compared to Cyclogest 400 mg, and what are the implications of this variability for dose-response relationships and future trial design?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex
- •Clinical diagnosis of luteal phase insufficiency on the basis of one of the following:
- •Spotting before first day of heavy menstrual bleeding
- •Short time between ovulation and menstruation
- •Symptoms of progesterone insufficiency
- •Aged 18 - 45 years
- •Experienced at least one previous miscarriage
排除标准
- •Positive pregnancy test
- •Currently breastfeeding
- •Allergies or contraindications to excipients / progesterone pessaries
- •Current or history of previous condition where hormone treatments are contraindicated e.g. breast cancer
- •Individuals who lack capacity to consent to the trial
- •Individuals who have an inability to comply with the trial procedures (e.g. cannot attend hospital for trial visits)
- •Inability to understand English
研究组 & 干预措施
Callavid 2-hr first, Cyclogest second, Callavid 3-hr third
Participants are randomised to use Callavid first for 2 hour wear before crossing over to use Cyclogest. In the third round, participants receive Callavid again but for 3 hour wear.
干预措施: 400mg progesterone Callavid - 2hr wear (Combination Product)
Callavid 2-hr first, Cyclogest second, Callavid 3-hr third
Participants are randomised to use Callavid first for 2 hour wear before crossing over to use Cyclogest. In the third round, participants receive Callavid again but for 3 hour wear.
干预措施: Cyclogest 400 mg (Drug)
Callavid 2-hr first, Cyclogest second, Callavid 3-hr third
Participants are randomised to use Callavid first for 2 hour wear before crossing over to use Cyclogest. In the third round, participants receive Callavid again but for 3 hour wear.
干预措施: 400mg progesterone Callavid - 3hr wear (Combination Product)
Cyclogest first, Callavid 2-hr second, Callavid 3-hr third
Participants are randomised to use Cyclogest first before crossing over to use Callavid for 2 hour wear. In the third round, participants receive Callavid again but for 3 hour wear.
干预措施: 400mg progesterone Callavid - 2hr wear (Combination Product)
Cyclogest first, Callavid 2-hr second, Callavid 3-hr third
Participants are randomised to use Cyclogest first before crossing over to use Callavid for 2 hour wear. In the third round, participants receive Callavid again but for 3 hour wear.
干预措施: Cyclogest 400 mg (Drug)
Cyclogest first, Callavid 2-hr second, Callavid 3-hr third
Participants are randomised to use Cyclogest first before crossing over to use Callavid for 2 hour wear. In the third round, participants receive Callavid again but for 3 hour wear.
干预措施: 400mg progesterone Callavid - 3hr wear (Combination Product)
结局指标
主要结局
Adverse events recorded from 400 mg progesterone Callavid
时间窗: From treatment up to 24 hours after the last dose
Any grade of adverse events, specifically allergy, gastrointestinal (bloating, constipation), neurological (headache, drowsiness, euphoria) according to Common Terminology Criteria for Adverse Events (CTCAE).
次要结局
- PROMIS Anxiety questionnaire(Day 1 and day 7 of treatment in each round (3 rounds total))
- Acceptability questionnaires(Day 1 and day 7 of treatment in each round (3 rounds total))
- Semi-structured user experience interviews(day 7)
- Delivery of vaginal progesterone into the blood at 2 hour and 3 hour wear(Multiple time points on Day 1 and Day 7 of each treatment)