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

NCT07136922 | Recruiting Phase 1

• 1 other identifier: SQ641924
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Luteal Phase Insuffiency; Progesterone Delivery

Keywords

progesterone delivery; progesterone; vaginal drug delivery; callavid; cyclogest; women's health

Outcome Measures

Primary Outcomes (1)

• 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).

  From treatment up to 24 hours after the last dose

Secondary Outcomes (4)

• 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

Study Arms (2)

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

ACTIVE COMPARATOR

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.

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

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

ACTIVE COMPARATOR

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.

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

Interventions

400mg progesterone Callavid - 2hr wear COMBINATION_PRODUCT

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

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

Cyclogest 400 mg DRUG

Cyclogest 400 mg pessary, twice daily for 7 days

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

400mg progesterone Callavid - 3hr wear COMBINATION_PRODUCT

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

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Assigned female at birth.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Calla Lily Clinical Care Ltd: lead
• University Hospitals Coventry and Warwickshire NHS Trust: collaborator
• University of Warwick: collaborator

Study Sites (1)

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

RECRUITING

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Central Study Contacts

Siobhan Quenby

CONTACT

+442476964000; s.quenby@warwick.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The trial consists of three rounds, conducted over three consecutive menstrual cycles. Participants are randomised to receive either Cyclogest 400mg progesterone pessary in the first round, crossing over to 400mg progesterone Callavid (administered for 2 hours) in the second round, or 400mg progesterone Callavid (administered for 2 hours) in the first round crossing over to Cyclogest 400mg progesterone pessary in the second round. The third round is to investigate the safety of 400mg progesterone Callavid when administered for 3 hours. This would inform us on the safety of the additional hour of wear time. Each arm will complete the third round following the first two crossover rounds.

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 22, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

GB (1)