Trial reportNaunyn-Schmiedeberg's archives of pharmacology2026
Bioequivalence study of Prontogest 100 mg/2 mL solution for intramuscular injection versus reference progesterone injection, USP 500 mg/10 mL under fasting conditions: a randomized, open-label, two-sequence, four-period, fully replicated crossover study in healthy postmenopausal women.
Trial report in Naunyn-Schmiedeberg's archives of pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
9 authors.
Funding
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Abstract
Intramuscular progesterone remains an important formulation when prolonged systemic exposure is needed in gynecology and reproductive medicine. Demonstrating bioequivalence between a generic product and the reference formulation is necessary to support therapeutic interchangeability. The objectiveof thisstudy is to compare the pharmacokinetics, bioequivalence, safety, and tolerability of Prontogest 100 mg/2 mL intramuscular injection with the reference progesterone injection after a single dose under fasting conditions. In this open-label, randomized, single-dose, two-treatment, two-sequence, four-period fully replicated crossover study, healthy postmenopausal women received the test or reference product according to TRTR or RTRT sequences, separated by 15-day washout periods. Blood samples were collected up to 72 h after each dose, and plasma progesterone concentrations were measured using a validated LC-MS/MS method. The primary pharmacokinetic endpoints were baseline-corrected C
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