Women who have had at least one miscarriage and have luteal phase progesterone insufficiency
IMP is 400 mg Progesterone Callavid used vaginally 2 x day for 7 days in each round. Comparator is 400mg Cyclogest used vaginally 2 x day for 7 days in each round. Arm 1: Callavid 2-hour first , Cyclogest second, Callavid 3-hour 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. Arm 2: Cyclogest first, Callavid 2-hour second, Callavid 3-hour third 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. Randomisation will be conducted by UHCW Pharmacy.
1. Female sex 2. Clinical diagnosis of luteal phase insufficiency on the basis of one of the following: 2.1. Spotting before first day of heavy menstrual bleeding 2.2. Short time between ovulation and menstruation 2.3. Symptoms of progesterone insufficiency 3. Aged 18 – 45 years 4. Experienced at least one previous miscarriage
1. Positive pregnancy test 2. Currently breastfeeding 3. Allergies or contraindications to excipients/ progesterone pessaries 4. Current or history of previous condition where hormone treatments are contraindicated, e.g. breast cancer 5. Individuals who lack capacity to consent to the trial 6. Individuals who have an inability to comply with the trial procedures (e.g. cannot attend hospital for trial visits) 7. Inability to understand English