Comparative Bioavailability of Two Daily Subcutaneous Doses Versus a Single Dose of Intramuscular and Vaginal Progesterone Formulations in Healthy Postmenopausal Females
Bibliographic record
Abstract
Abstract Progesterone is a naturally occurring endocrine hormone. It is used for luteal phase support to improve success rates in assisted reproduction. This was a single‐center, comparative bioavailability, open‐label, randomized, 3‐period, 6‐sequence, crossover study to compare the rate and extent of absorption of subcutaneous (SC) progesterone 25 mg twice daily, versus vaginal (Vag) gel once daily (90 mg progesterone) and 50 mg of intramuscular (IM) progesterone injection once daily in healthy postmenopausal females. Eighteen healthy, postmenopausal, female nonsmokers aged 55–65 years were dosed. Data from 17 subjects who completed at least 2 study periods, including the test and 1 reference, were included in the pharmacokinetic analysis. The SC progesterone product administered twice daily showed a higher exposure than a single dose of the Vag formulation, with least‐squares mean (LSM) ratios (SC/Vag gel) of 219.7% for AUC0–inf and 391.8% for Cmax. The SC progesterone product administered twice daily showed comparable extent of exposure to that of the IM product, but showed higher peak concentration, with LSM ratios (SC/IM) of 92.4% for AUC0–inf and 138.0% for Cmax. Mean (SD) relative bioavailability (Frel) for SC/Vag gel was 449.6 (233.1)%, and for SC/IM was 92.3 (6.3)%. Mild injection site reactions were reported with similar frequency for SC and IM progesterone. With further research, twice‐daily SC progesterone may offer an alternative to existing available treatments for luteal phase support.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".