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Design: single-centre, randomised, open-label, single and multiple-day (5 days) parallel design pharmacokinetic study

Participants: 18 healthy women aged 18 to 40

Main outcome measures: pharmacokinetic profiles

Comparator agents: Endometrin® (100 mg vaginal progesterone tablets; marketed as Lutigest® in the UK) twice daily (n = 6), three times daily (n = 6), and 8% progesterone vaginal gel (90 mg) daily (n = 6).



Progesterone serum concentrations increased rapidly following administration of Lutigest®, producing higher peak concentrations (Cmax) and clearing faster than gel. On the single day of dosing, mean Cmax was 17.0+/-2.7 ng/mL in the two times a day group, 19.8+/-2.9 ng/mL in the three times a day group, and 6.82+/-1.69 ng/mL in the gel group.

Lutigest® reached steady state within the first 2 days (24-36 hours), much more rapidly than the gel, which had not reached steady state by 5 days.

At 5 days, Lutigest® produced sustained progesterone concentrations exceeding 10 mg/mL across 24 hours.



Lutigest® reached higher Cmax, produced greater systemic exposure (area under the curve 0-24), achieved steady state more rapidly, and cleared more rapidly after termination of therapy than the vaginal gel comparator.



  1. Lutigest Summary of Product Characteristics. Lutigest 100 mg vaginal tablets Available: (last accessed on 01-September-2023).
  2. Blake, EJ et al. Fertil Steril 2010; 94: 1296-301.

Job Code: UK-LUG-2300004 - Date of preparation: September 2023


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