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

Phase 1Not Yet RecruitingNCT07136922

Calla Lily Clinical Care Ltd20 enrolled

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 (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?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Luteal Phase Insuffiency Progesterone Delivery

Interventions

400mg progesterone Callavid - 2hr wearCOMBINATION_PRODUCT

400mg progesterone Callavid, 2 hour wear, twice daily for 7 days

Cyclogest 400 mgDRUG

Cyclogest 400 mg pessary, twice daily for 7 days

400mg progesterone Callavid - 3hr wearCOMBINATION_PRODUCT

400mg progesterone Callavid, 3 hour wear, twice daily for 7 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Adverse events recorded from 400 mg progesterone Callavid

Any grade of adverse events, specifically allergy, gastrointestinal (bloating, constipation), neurological (headache, drowsiness, euphoria) according to Common Terminology Criteria for Adverse Events (CTCAE).

Time frame: From treatment up to 24 hours after the last dose

Secondary Outcomes

PROMIS Anxiety questionnaire

PROMIS short 4-item anxiety fear instrument

Time frame: Day 1 and day 7 of treatment in each round (3 rounds total)

Acceptability questionnaires

User acceptability questionnaires on 400mg progesterone Callavid

Time frame: Day 1 and day 7 of treatment in each round (3 rounds total)

Semi-structured user experience interviews

Semi-structured interviews with participants after completion of the crossover rounds.

Time frame: day 7

Delivery of vaginal progesterone into the blood at 2 hour and 3 hour wear

The serum progesterone levels at time 0, 3- and 6-hour after the first dose on day 1 and the thirteenth dose which is on day 7 each round of treatment are measured. Progesterone levels are measured for both 400 mg progesterone Callavid and 400 mg Cyclogest.

Time frame: Multiple time points on Day 1 and Day 7 of each treatment