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Condition (MeSH)

Disorders of Sex Development

ClinicalTrials.gov lists 412 trials for Disorders of Sex Development or a narrower condition beneath it. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has the most among industry and government lead sponsors, with 17.

MeSH D012734 Urogenital Diseases C12 C16 C19 Listed by Orphanet as a rare disease
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Phase 1 Phase 1 22 Phase 1/2 Phase 1/2 10 Phase 2 Phase 2 56 Phase 2/3 Phase 2/3 3 Phase 3 Phase 3 35 Phase 4 Phase 4 34 Not applicable Not applicable 69 Observational Observational 183 Phase 1 Phase 1 22 Phase 1/2 Phase 1/2 10 Phase 2 Phase 2 56 Phase 2/3 Phase 2/3 3 Phase 3 Phase 3 35 Phase 4 Phase 4 34 Not applicable Not applicable 69 Observational Observational 183

Trials per phase (log scale)

31 of the 412 trials are tagged with Disorders of Sex Development itself; the rest are tagged with a narrower condition beneath it.

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The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Disorders of Sex Development trials start? (36)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year.

Trials over time, by phase

  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational

Top of scale: 25

1990: 2 trials (Not applicable 1, Phase 2 1) 1992: 3 trials (Phase 4 1, Phase 3 1, Phase 2 1) 1993: 1 trials (Phase 2 1) 1994: 1 trials (Observational 1) 1995: 2 trials (Not applicable 1, Phase 3 1) 1996: 2 trials (Not applicable 1, Phase 4 1) 1997: 2 trials (Observational 1, Phase 3 1) 1998: 1 trials (Phase 3 1) 1999: 5 trials (Observational 1, Not applicable 1, Phase 3 1, Phase 2 1, Phase 1 1) 2000: 4 trials (Observational 3, Phase 3 1) 2001: 6 trials (Observational 2, Not applicable 1, Phase 3 1, Phase 2 2) 2002: 2 trials (Observational 1, Not applicable 1) 2003: 1 trials (Observational 1) 2004: 5 trials (Observational 3, Phase 4 1, Phase 3 1) 2005: 9 trials (Observational 4, Phase 4 4, Phase 3 1) 2006: 12 trials (Observational 7, Not applicable 3, Phase 2 2) 2007: 13 trials (Observational 8, Not applicable 4, Phase 1/2 1) 2008: 10 trials (Observational 7, Not applicable 1, Phase 2 1, Phase 1 1) 2009: 13 trials (Observational 6, Not applicable 1, Phase 4 3, Phase 2/3 1, Phase 1 2) 2010: 16 trials (Observational 4, Not applicable 4, Phase 4 1, Phase 3 3, Phase 2 1, Phase 1/2 1, Phase 1 2) 2011: 11 trials (Observational 4, Not applicable 3, Phase 4 1, Phase 1 3) 2012: 23 trials (Observational 15, Not applicable 4, Phase 2/3 1, Phase 2 2, Phase 1 1) 2013: 19 trials (Observational 10, Not applicable 3, Phase 4 1, Phase 3 1, Phase 2 3, Phase 1 1) 2014: 14 trials (Observational 6, Not applicable 4, Phase 4 1, Phase 2 1, Phase 1/2 2) 2015: 18 trials (Observational 12, Not applicable 2, Phase 4 1, Phase 2 2, Phase 1 1) 2016: 22 trials (Observational 7, Not applicable 4, Phase 4 3, Phase 3 3, Phase 2 4, Phase 1 1) 2017: 13 trials (Observational 3, Not applicable 3, Phase 4 2, Phase 3 1, Phase 2 2, Phase 1 2) 2018: 19 trials (Observational 7, Not applicable 5, Phase 4 1, Phase 3 1, Phase 2 4, Phase 1/2 1) 2019: 13 trials (Observational 5, Not applicable 3, Phase 4 1, Phase 2 2, Phase 1 2) 2020: 14 trials (Observational 8, Not applicable 2, Phase 4 1, Phase 3 1, Phase 2 2) 2021: 25 trials (Observational 14, Not applicable 1, Phase 4 2, Phase 3 2, Phase 2 4, Phase 1/2 1, Phase 1 1) 2022: 19 trials (Observational 10, Not applicable 2, Phase 4 1, Phase 3 3, Phase 2 1, Phase 1/2 1, Phase 1 1) 2023: 16 trials (Observational 6, Not applicable 3, Phase 3 3, Phase 2 4) 2024: 19 trials (Observational 9, Not applicable 4, Phase 4 1, Phase 3 1, Phase 2 2, Phase 1/2 2) 2025: 20 trials (Observational 6, Not applicable 4, Phase 4 3, Phase 3 3, Phase 2 4)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 28
2025 20
2024 19
2023 16
2022 19
2021 25
2020 14
2019 13
2018 19
2017 13

Showing 10 of 36 earlier years.

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Forecast of the full-year count, planned starts included, not rows of this table: about 32 trials starting in 2026 and about 23 in 2027, the average of the 24 months through September, counted as registered and carried forward, with about 0.7 times the starts already registered for the rest of 2026 added. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 15 percent and ran about 1 percent high against the count later registered; forecasts made before the year began were off by about 26 percent and ran about 20 percent low against the count later registered. The part-way figures are from forecasts that used a multiple fitted only on earlier years. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Prediction, not a registry value: median of 36 months from start to primary completion across 32 trials still running at the 2026-10-09 snapshot; registered median of 33 months across 213 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Disorders of Sex Development trials in? (8)

Shown in this order: phase order.

Show the trials by phase as a table
Trials by phase
Phase Trials
Phase 1 22
Phase 1/2 10
Phase 2 56
Phase 2/3 3
Phase 3 35
Phase 4 34
Not applicable 69
Observational 183

How many Disorders of Sex Development trials are recruiting? (9)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 17
Recruiting 71
Enrolling by invitation 8
Active, not recruiting 14
Completed 198

Showing 5 of 9 statuses.

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Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Disorders of Sex Development trials? (7)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 17
Novo Nordisk A/S 12
Neurocrine UK Limited 8
Rhythm Pharmaceuticals, Inc. 7
Natera, Inc. 6

Showing 5 of 7 sponsors.

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Which drugs are being tested for Disorders of Sex Development? (6)

Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.

Drugs tested
Drug Trials
GnRH 8
Estradiol 7
Crinecerfont 6
Exenatide 5
Setmelanotide 4

Showing 5 of 6 drugs.

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Interventions as named in the registry (9)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
somatropin AQ 27
Hydrocortisone 1% 13
1% Metformin 11
Chronocort 7
r-hCG 4

Showing 5 of 9 interventions.

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These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Disorders of Sex Development trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Gastroenteritis 15 9
Vomiting 15 6
Pyrexia 13 5
Sepsis 12 2
Pneumonia 11 7

Showing 5 of 10 adverse events.

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Which publications cover Disorders of Sex Development? (29)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Publications
Publication Journal Year Major topic
How Far Should We Explore Hypospadias? Next-generation Sequencing Applied to a Large Cohort of Hypospadiac Patients. European urology 2021 Yes
Sex Differences in Reproductive Hormones During Mini-Puberty in Infants With Normal and Disordered Sex Development. The Journal of clinical endocrinology and metabolism 2018 Yes
Sexual function in adult life following Passerini-Glazel feminizing genitoplasty in patients with congenital adrenal hyperplasia. The Journal of urology 2014 Yes
Are the new policies on hyperandrogenism in elite female athletes really out of bounds? Response to "out of bounds? A critique of the new policies on hyperandrogenism in elite female athletes". The American journal of bioethics : AJOB 2013 Yes
Molecular diagnosis of 5α-reductase deficiency in 4 elite young female athletes through hormonal screening for hyperandrogenism. The Journal of clinical endocrinology and metabolism 2013 Yes

Showing 5 of 29 publications.

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Rare-disease identity (2)

Shown in this order: exact, broader, narrower, other.

Rare-disease identity
Orphanet disease ORPHA code Relation Source
Difference of sex development 90771 Exact Orphanet Rare Disease Ontology (ORDO)
Difference of sex development 90771 Exact Orphadata Science knowledge files, Product 1

Sub-conditions in MeSH (6)

MeSH descendants one level down with at least one trial, most trials first.

Not on this page

Not measured: delivery record.

Checked, with nothing recorded for this condition: prevalence.

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