An observational study in Prolactinoma and Macroprolactinoma, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Hospices Civils de Lyon · Observational
Prolactinomas are the most common pituitary adenomas, representing about two-thirds of clinically relevant cases. Their prevalence is around 50 per 100,000 individuals, with an incidence of 3-5 new cases per 100,000 per year and has been rising in recent decades.
They may increase morbidity and mortality due to several factors:
A marked sex difference exists, with a male-to-female ratio of 1:5-1:10, and peak diagnosis in women aged 25-44. This disparity disappears after menopause, supporting a potential role of estrogens in tumor development. Lactotrope cells, from which prolactinomas arise, are estrogen-sensitive, unlike other pituitary tumor cells (e.g., somatotrophs, gonadotrophs).
A large 2022 prospective cohort (nurses) suggested a possible association between pituitary adenomas and both combined oral contraceptives (COCs) and hormone therapy (HT). However, limitations included self-reported diagnoses, lack of adenoma characterization, and contradictory findings (association with HT but not consistently with COCs). A 2009 case-control study including all adenomas found no link with hormonal contraception, while older studies from the 1980s assessed high-dose contraceptives no longer in use.
Microprolactinomas are 4-5 times more frequent than macroprolactinomas (≥10 mm). Distinguishing between the two is essential, as they differ in clinical presentation, prognosis, and sex distribution. Macroadenomas are more common in men, possibly due to delayed diagnosis, as symptoms such as decreased libido are less specific, whereas women often present with amenorrhea or galactorrhea. However, studies suggest tumor size is not directly linked to symptom duration, indicating other factors may explain macroadenoma development.
Why some patients develop macro- rather than microadenomas remains unclear. Estrogen exposure is a possible explanation. It is therefore relevant to investigate whether women with macroprolactinomas had greater exposure to endogenous estrogens (early menarche, late menopause, pregnancies, breastfeeding) or exogenous estrogens (contraception, menopausal HT) compared to women with microprolactinomas.
The hypothesis is that women with macroprolactinomas were exposed to higher cumulative levels of estrogens before diagnosis than women with microprolactinomas.
28 studies on the registry are indexed under Prolactinoma; 5 are open to participants now.
This study's enrollment of 171 is below the median of 530 across 13 observational studies indexed under Prolactinoma.
Browse Prolactinoma studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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").
Inclusion Criteria of cases :
Inclusion Criteria of controls :
Exclusion Criteria of cases :
Exclusion Criteria of controls :
Women with prolactin-producing macroadenomas diagnosed between 2013 and 2023 Followed by the Hospices Civiles de Lyon, Hôpital Cardiologique of Bron.
Other: Standardized questionnaire
Women with prolactin-producing microadenomas diagnosed between 2013 and 2023 Followed by the Hospices Civiles de Lyon, Hôpital Cardiologique of Bron.
Other: Standardized questionnaire
The intervention is a questionnaire which will be administered only if informations available on medical files are not sufficient. 1 mounth before questionning our cases and controls, they will receive a participant information note. It will be administered primarily by telephone. If the patient prefers not to answer by telephone, a paper version will be mailed to her. In this case, she will have up to two months to return the completed questionnaire by post. The questionnaire will collect detailed information on potential exposures to estrogens and reproductive history.
number of patients exposed to combined estrogen-progestin contraception
Identify the estrogen-dependent risk factor
Time frame: week 4
number of patients exposed to menopausal hormone therapy
Identify the estrogen-dependent risk factor
Time frame: week 4
number of patients exposed to progestin-only treatment
Identify the estrogen-dependent risk factor
Time frame: week 4
number of patients exposed to Ovarian Stimulation
Identify the estrogen-dependent risk factor
Time frame: week 4
Age at First Use of Hormonal Contraception
Identify the estrogen-dependent risk factor
Time frame: week 4
Age at Menarche
Identify the estrogen-dependent risk factor
Time frame: week 4
Age at Menopause
Identify the estrogen-dependent risk factor
Time frame: week 4
Age at First Live Birth
Identify the estrogen-dependent risk factor
Time frame: week 4
Nulliparity
Identify the estrogen-dependent risk factor
Time frame: week 4
Number of Pregnancies Carried to Viability
Identify the estrogen-dependent risk factor
Time frame: week 4
Exposure to Breastfeeding defined as the total cumulative duration of breastfeeding across all pregnancies, expressed in months. • None: 0-1 month • Moderate: 1-12 months • High: >12 months
Identify the estrogen-dependent risk factor
Time frame: week 4
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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