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

Calla Lily Clinical Care Ltd

Status and phase: Begins enrollment in 2 months; Phase 1

Conditions: Luteal Phase Insuffiency; Progesterone Delivery

Treatments: Drug: Cyclogest 400 mg; Combination Product: 400mg progesterone Callavid - 2hr wear; Combination Product: 400mg progesterone Callavid - 3hr wear

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07136922

SQ641924

Details and patient eligibility

About

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?

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Callavid 2-hr first, Cyclogest second, Callavid 3-hr third

Active Comparator group

Description:

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.

Treatment:

Combination Product: 400mg progesterone Callavid - 3hr wear

Combination Product: 400mg progesterone Callavid - 2hr wear

Drug: Cyclogest 400 mg

Cyclogest first, Callavid 2-hr second, Callavid 3-hr third

Active Comparator group

Description:

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.

Treatment:

Combination Product: 400mg progesterone Callavid - 3hr wear

Combination Product: 400mg progesterone Callavid - 2hr wear

Drug: Cyclogest 400 mg