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| Name | Class |
|---|---|
| University Hospitals Coventry and Warwickshire NHS Trust | OTHER |
| University of Warwick | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 400mg progesterone Callavid - 2hr wear | Combination Product | 400mg progesterone Callavid, 2 hour wear, twice daily for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Anxiety questionnaire | PROMIS short 4-item anxiety fear instrument | Day 1 and day 7 of treatment in each round (3 rounds total) |
| Acceptability questionnaires | User acceptability questionnaires on 400mg progesterone Callavid |
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Inclusion Criteria:
Exclusion Criteria:
Assigned female at birth.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siobhan Quenby | Contact | +442476964000 | s.quenby@warwick.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Coventry & Warwickshire NHS Trust | Recruiting | Coventry | CV2 2DX | United Kingdom |
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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.
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| Cyclogest 400 mg | Drug | Cyclogest 400 mg pessary, twice daily for 7 days |
|
| 400mg progesterone Callavid - 3hr wear | Combination Product | 400mg progesterone Callavid, 3 hour wear, twice daily for 7 days |
|
| 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. | 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. | Multiple time points on Day 1 and Day 7 of each treatment |
| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
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