Could estrogen exposure explain why some pituitary tumors grow larger?
NCT ID NCT07268183
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study investigates whether higher lifetime exposure to estrogen—from sources like birth control, pregnancy, or hormone therapy—is linked to the development of larger prolactin-secreting pituitary tumors (macroprolactinomas) compared to smaller ones (microprolactinomas). Researchers will compare estrogen exposure histories in 180 women diagnosed with either type of tumor. The goal is to identify potential risk factors that might explain why some tumors grow larger.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If this study finds a link, it could help doctors understand why some women develop larger prolactinomas and possibly guide future prevention or monitoring strategies.
- What could go wrong
- This is an observational study using questionnaires, so it cannot prove cause and effect. Results may be limited by recall bias or other unmeasured factors.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients included in this study will be identified from the COLLEMARA database, used within the Hospices Civils de Lyon. This database, specifically dedicated to rare diseases, provides a structured registry of patients followed for rare pituitary disorders, such as prolactinomas. For the purpose of this study, the COLLEMARA database will be used solely to identify eligible patients, based on the coded diagnosis of "prolactinoma." The study population will consist of female patients whose diagnosis was made between 2013 and 2023 and who meet the other inclusion criteria. A total of 180 patients will be included: 60 in the case group ("macroprolactinomas") and 120 in the control group ("microprolactinomas").
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria of cases : * Female patients aged ≥ 18 years at recruitment (diagnosis may have occurred before age 18). * Diagnosis of a prolactin-secreting macroadenoma established between January 2013 and December 2023. The diagnosis may have been made either in the Endocrinology Department of Hôpital Louis Pradel or by another medical team, whether within or outside the hospital setting. However, follow-up or part of the follow-up must have been performed in the Endocrinology Department of Hospices Civils de Lyon (HCL) * Diagnosis established by : A hypothalamic-pituitary MRI centered on the sella turcica, performed with gadolinium injection, including fine T1-weighted coronal and sagittal slices (1.5-3 mm), showing an adenoma with at least one axis measuring \> 10 mm, AND Serum prolactin \> 100 µg/L, or 24-100 µg/L with either a favorable response to medical therapy or histopathological confirmation after surgery. * Ability to understand the study and provide informed non-opposition. Inclusion Criteria of controls : * Female patients aged ≥ 18 years at the time of recruitment (diagnosis may have occurred before age 18). * Diagnosis of a prolactin-secreting microadenoma established between January 2013 and December 2023. The diagnosis may have been made in any medical center, but follow-up or part of the follow-up must have been carried out in the Endocrinology Department of Hôpital Louis Pradel. * Diagnosis must be based on: A hypothalamic-pituitary MRI centered on the sella turcica, performed with gadolinium injection, including fine T1-weighted coronal and sagittal slices (1.5-3 mm), showing a prolactin-secreting adenoma with all axes measuring \< 10 mm, AND A biological assessment performed outside any condition likely to bias results (significant stress, physical exertion, pregnancy, or intake of hyperprolactinemia-inducing drugs unrelated to prolactinoma treatment), showing serum prolactin \> 24 µg/L. * Ability to understand the nature and implications of the study and to provide informed non-opposition to participation. Exclusion Criteria of cases : * Presence of a non-secreting macroadenoma. * History of isolated hyperprolactinemia or an isolated pituitary lesion documented prior to 2013, without subsequent direct diagnosis of prolactinoma. * Presence of a known genetic abnormality or a genetic syndrome predisposing to the development of a prolactin-secreting adenoma. Exclusion Criteria of controls : * Presence of a non-secreting microadenoma. * Uncertain diagnosis of adenoma with an ongoing therapeutic trial. * Isolated hyperprolactinemia without evidence of adenoma. * Hyperprolactinemia or pituitary lesion without hyperprolactinemia documented prior to 2013, without subsequent direct diagnosis of prolactinoma. * Presence of a known genetic abnormality or a genetic syndrome predisposing to the development of a prolactin-secreting adenoma
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hopital Louis Pradel
RECRUITINGBron, Rhone, 69500, France
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- What do patients and doctors really think about prolactinoma care?