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Recruiting NCT07136922

First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency

Phase I Interventional Luteal Phase Insuffiency Progesterone Delivery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 400mg progesterone Callavid - 2hr wear, Cyclogest 400 mg, 400mg progesterone Callavid - 3hr wear.
Who it may be relevant to
Registry conditions: Luteal Phase Insuffiency, Progesterone Delivery. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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: 1. 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)? 2. What is usability experience for patients using the Callavid drug-device combination compared to pessaries / suppositories (i.e. Cyclogest 400 mg)? 3. 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?

Interventions

  • Combination product 400mg progesterone Callavid - 2hr wear
    400mg progesterone Callavid, 2 hour wear, twice daily for 7 days
  • Drug Cyclogest 400 mg
    Cyclogest 400 mg pessary, twice daily for 7 days
  • Combination product 400mg progesterone Callavid - 3hr wear
    400mg progesterone Callavid, 3 hour wear, twice daily for 7 days

Primary outcome measures

  • Adverse events recorded from 400 mg progesterone Callavid [Time frame: From treatment up to 24 hours after the last dose]
Secondary outcome measures (4)
  • PROMIS Anxiety questionnaire [Time frame: Day 1 and day 7 of treatment in each round (3 rounds total)]
  • Acceptability questionnaires [Time frame: Day 1 and day 7 of treatment in each round (3 rounds total)]
  • Semi-structured user experience interviews [Time frame: day 7]
  • Delivery of vaginal progesterone into the blood at 2 hour and 3 hour wear [Time frame: Multiple time points on Day 1 and Day 7 of each treatment]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • University Hospitals Coventry & Warwickshire NHS Trust — Coventry

Identifiers

NCT: NCT07136922 · SQ641924

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗