progesterone: clinical use

Prescribing considerations

• Confirm the indication and select a licensed formulation; oral, vaginal and rectal products are not automatically interchangeable.
• For HRT, assess combined oestrogen–progesterone benefits and risks and whether the patient has an intact uterus.
• Investigate unexplained vaginal bleeding before treatment.
• Review thromboembolic, hormone-sensitive cancer, hepatic, mood, migraine, cardiovascular and metabolic history.
• Selected Besins capsules contain soya lecithin and are contraindicated with relevant soya or peanut allergy.
• For preterm-birth prevention, confirm that the pregnancy and risk profile match the licensed Cyclogest population.

Contraindications and cautions

• Hypersensitivity to progesterone or product excipients
• Undiagnosed vaginal bleeding
• Known or suspected relevant hormone-sensitive malignancy
• Active or previous serious arterial or venous thromboembolic disease, depending on product
• Severe hepatic dysfunction or disease
• Porphyria
• Known missed miscarriage; some fertility products also contraindicate ectopic pregnancy
• Preterm premature rupture of membranes for Cyclogest used to prevent preterm birth
• Relevant soya or peanut allergy for selected Besins capsules

Monitoring

• Investigate new, persistent or heavy vaginal bleeding.
• Monitor for thromboembolic, neurological, visual or hepatic warning symptoms.
• Review mood in patients with current or previous depression.
• Consider closer glucose monitoring in diabetes or impaired glucose tolerance.
• Review fluid-retention-sensitive conditions such as epilepsy, migraine, asthma, cardiac or renal dysfunction.
• For HRT, reassess ongoing need, bleeding pattern and overall benefit–risk balance.

Clinical pharmacology

Micronised progesterone acts at progesterone receptors to convert proliferative endometrium into secretory endometrium. Oral administration undergoes gastrointestinal absorption and hepatic metabolism; vaginal administration avoids much first-pass metabolism and can produce preferential uterine exposure.

Formulation and product differences

• Progesterone Besins soft capsules are licensed for oral HRT use with oestrogen.
• Utrogestan Vaginal capsules and Lutigest vaginal tablets provide luteal support during assisted reproduction.
• Lutigest has a reusable applicator; Crinone is a bioadhesive vaginal gel in a single-use applicator.
• Cyclogest is a vaginal or rectal pessary with distinct licensed indications.
• Excipients differ, including soya lecithin in selected capsules, lactose in Lutigest and sorbic acid in Crinone.

Capsule

Route: Oral

Strengths: 100 mg, 200 mg, 300 mg, 400 mg

Vaginal gel

Route: Vaginal

Strengths: 8%