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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

"Quick-starting" of a Quadriphasic Contraceptive Pills, 1 - 3 mg Estradiol Valerate/ 2 - 3 mg Dienogest VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition

NCT06396208

Ultrasound Finding: Ovulation Inhibition, Ovarian Activities Cervical Mucus Serum Hormonal Profile

COMPLETED NA

Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle

NCT02817464

Pregnancy Contraception

COMPLETED PHASE1

A Study to Determine the Effects of PF-04965842 on the Pharmacokinetics of Oral Contraceptive Steroids in Healthy Female Subjects

NCT03662516

Healthy Females

COMPLETED PHASE1

Comparative Bioavailability of Two Injectable Suspension Formulations of Medroxyprogesterone Acetate+Estradiol Cypionate

NCT03443089

Contraception

COMPLETED PHASE1

Progesterone in Luteal Phase Deficiency

NCT02950948

Luteal Phase Defect

WITHDRAWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Luteal Phase Insuffiency Progesterone Delivery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR