An observational study in Contraception and Macro-progestins, sponsored by Assistance Publique - Hôpitaux de Paris. Withdrawn at 1 site in France. Open to female participants aged 16 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
Many factors are known to influence the acquisition of bone capital, especially estrogens in women. Estrogens have a major role in bone growth and the acquisition of bone mass peaks during puberty. This peak of bone mass is an important determinant of the risk of osteoporotic fracture in adulthood.
It is known that estrogen deficiency increases the rate of bone remodeling and engenders an imbalance between resorption and bone formation, which can lead to osteoporosis.
Oral estroprogestin contraceptives have an anti-gonadotropic effect and suppress estrogen secretion by the ovaries.
However, studies in adolescents and young adults are rare and evidence of an effect on bone is still inconclusive, although there is increasing evidence that oral estroprogestin contraceptives in teenage girls may compromise the performance of the bone mass.
Macro progestins treatments are prescribed in France to patients with contraindications to estroprogestin treatments. This practice is french and few recommendations exist on the use of these molecules by the oral route. There are no studies that describe the impact of these oral treatments on the bone health of young women treated.
The Department of endocrinology, gynecology and pediatric diabetes of Necker-Enfants Malades hospital, follows many young girls taking a macro progestin treatment. This study is exclusively descriptive and will focus on the clinical and medical datas available on the bone health of these patients.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients followed by the department of endocrinology, gynecology and pediatric diabetes of Necker hospital.
Exclusion Criteria:
Patients who have taken a macro progestin treatment for more than 6 months between 16 and 25 years of age.
Other: Questionnaire
Fardellone questionnaire (evaluation of calcium intake) Tolerance of treatment
Bone densitometry
Z score values compared to the reference values
Time frame: Day 0
Calcemia
Blood test
Time frame: Day 0
Ionized calcium
Blood test
Time frame: Day 0
Phosphor
Blood test
Time frame: Day 0
Magnesium
Blood test
Time frame: Day 0
Albumin
Blood test
Time frame: Day 0
Parathormone
Blood test
Time frame: Day 0
25 OH vitamin D3
Blood test
Time frame: Day 0
Creatinine
Blood test
Time frame: Day 0
Osteocalcin
Blood test
Time frame: Day 0
Bone alkaline phosphatase isoenzymes
Blood test
Time frame: Day 0
C-terminal telopeptide of type I collagen
Blood test
Time frame: Day 0
Calciuria
Urine test
Time frame: Day 0
Natriuresis
Urine test
Time frame: Day 0
Creatinuria
Urine test
Time frame: Day 0
Clinical tolerance of treatment
6 questions asked to the patient under treatment, a yes or no answer is expected : presence of menstruating, regularity of cycles, out-of-periods bleeding, weight gain, acne, satisfaction in relation to treatment.
Time frame: Day 0
Follicle stimulating hormone
Blood test, patients under macro progestin treatment at day 0
Time frame: Day 0
Gonadotrophin b LH
Blood test, patients under macro progestin treatment at day 0
Time frame: Day 0
Estradiol
Blood test, patients under macro progestin treatment at day 0
Time frame: Day 0
This study is withdrawn, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris