Phase II
Women's & Reproductive Health
Pain rank 46 of 76, volume rank 62 of 76 by industry trials. Trials here sit close to the map median on both amendments and enrollment failure.
What this is worth
The amendment proxy, priced. Order of magnitude, anchor cited, assumptions on the table.
Per 100 industry trials in this cell, about 40 rewrite their eligibility criteria at least once. At the industry average of $450k direct cost per amendment, with the 6+ weeks of delay each not even counted, that is at least $18M at stake per 100 trials. Across the roughly 288 industry trials here, the floor is $51M.
Assumes $450k direct cost per amendment (industry average; Phase II median runs lower, Phase III higher, and delay cost is excluded), applied to the proxy rate. The proxy counts only trials with at least one eligibility change, so this understates the true exposure. How this is derived.
The signals
Industry sponsors first, since that is the commercial buyer, each figure shown against the map median. All-sponsor figures follow. A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.
- Eligibility amendments
- 40%vs map 40%proxyn = 48sampled
- Enrollment failure
- 15%vs map 13%n = 249concluded
- Startup lag
- 35 dvs map 45.5 dn = 125with dates
- Median duration
- 14.4 mon = 270completed
- Eligibility amendments
- 33%proxyn = 90sampled
- Enrollment failure
- 16%n = 663concluded
- Startup lag
- 58 dn = 414with dates
- Median duration
- 17.7 mon = 871completed
Why these trials stoppedsafety or tolerability leads
The most common category here is safety or tolerability (9 of 37 stopped). A keyword pass runs first; free text it could not place was sorted once by a frozen AI classification into these same categories, auditable rather than a live model. "No enrollment recorded (inferred)" is not a stated reason: it is read from a zero enrollment count, meaning the trial never enrolled anyone. "Not reported" means the sponsor left the field blank, shown rather than hidden.
Evidence12 trials
A sample of terminated or withdrawn trials in this cell. Each links to its ClinicalTrials.gov record.
| Trial | Sponsor | Status | Stated reason |
|---|---|---|---|
| NCT06986031 | Prokrea BCN, S.L. | terminated | Low accrual |
| NCT05571111 | Ferring Pharmaceuticals | withdrawn | Low accrual |
| NCT05403476 | Ferring Pharmaceuticals | terminated | Low accrual |
| NCT05370521 | Spruce Biosciences | terminated | Sponsor decision |
| NCT04614246 | Bayer | terminated | Sponsor decision |
| NCT04174911 | Breath of Life International Pharma Ltd | withdrawn | Logistics or operations |
| NCT04159493 | Aspen USA Inc | withdrawn | Sponsor decision |
| NCT03598777 | Ipsen | terminated | Efficacy or futility |
| NCT03573336 | Bayer | terminated | Sponsor decision |
| NCT03481842 | BioGene Pharmaceutical Ltd. | withdrawn | Sponsor decision |
| NCT03373422 | Bayer | terminated | Safety or tolerability |
| NCT02865915 | Millendo Therapeutics US, Inc. | terminated | Safety or tolerability |