ContraceptionMACROSNCT04007614
Bone Health in Adolescents and Young Adults With Oral Macro-progestin Treatment
An observational study of Contraception and Macro-progestins, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 25 years, women only
- Conditions the study is for
- Contraception, Macro-progestins
- What is being tested?
- Questionnaire
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2020to Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Patients followed by the department of endocrinology, gynecology and pediatric diabetes of Necker hospital.
Who may be able to join
- Patients aged 16 to 25 years old
- Patients followed at Necker-Enfants Malades hospital
- Patients who have taken or taking macro-progestins treatment by oral route (Luteran, Lutenyl, Surgestone) for at least 6 months between the age of 16 and 25 years
Who cannot join
- Patients with a pathology or treatment that can alter bone mineral density
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bone Health in Adolescents and Young Adults With Oral Macro-progestin Treatment : Observational Study
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.
Read more
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.
- Conditions
- Contraception, Macro-progestins
- Being tested
- Questionnaire
- Keywords
- Macro-progestins, Bone health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Fardellone questionnaire (evaluation of calcium intake) Tolerance of treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients who have taken a macro progestin treatment for more than 6 months between 16 and 25 years of age. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone densitometry
Z score values compared to the reference values
Measured: Day 0
Calcemia
Blood test
Measured: Day 0
Ionized calcium
Blood test
Measured: Day 0
Phosphor
Blood test
Measured: Day 0
Magnesium
Blood test
Measured: Day 0
Albumin
Blood test
Measured: Day 0
Parathormone
Blood test
Measured: Day 0
25 OH vitamin D3
Blood test
Measured: Day 0
Creatinine
Blood test
Measured: Day 0
Osteocalcin
Blood test
Measured: Day 0
Bone alkaline phosphatase isoenzymes
Blood test
Measured: Day 0
C-terminal telopeptide of type I collagen
Blood test
Measured: Day 0
Calciuria
Urine test
Measured: Day 0
Natriuresis
Urine test
Measured: Day 0
Creatinuria
Urine test
Measured: Day 0
Secondary outcomes (4)
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.
Measured: Day 0
Follicle stimulating hormone
Blood test, patients under macro progestin treatment at day 0
Measured: Day 0
Gonadotrophin b LH
Blood test, patients under macro progestin treatment at day 0
Measured: Day 0
Estradiol
Blood test, patients under macro progestin treatment at day 0
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study startApr 2020 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Why it stopped: The study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Sabrina Da Costa, MD, Study director, Hôpital Necker-Enfants Malades
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007614
- Sponsor's protocol ID
- APHP190093
- Other IDs
- IDRCB : 2019-A00340-57
- Acronym
- MACROS
- Status last verified
- Mar 2026
- First submitted
- 17 Apr 2019
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Health in Adolescents and Young Adults With Oral Macro-progestin Treatment : Observational Study
- ClinicalTrials.gov ID
- NCT04007614
- Acronym / sponsor ID
- MACROS / APHP190093
- Conditions
- Contraception, Macro-progestins
- Keywords
- Macro-progestins, Bone health
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Apr 2020 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: QuestionnairePatients who have taken a macro progestin treatment for more than 6 months between 16 and 25 years of age. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients followed by the department of endocrinology, gynecology and pediatric diabetes of Necker hospital.
Key inclusion criteria (3 listed)
- Patients aged 16 to 25 years old
- Patients followed at Necker-Enfants Malades hospital
- Patients who have taken or taking macro-progestins treatment by oral route (Luteran, Lutenyl, Surgestone) for at least 6 months between the age of 16 and 25 years
Key exclusion criteria (1 listed)
- Patients with a pathology or treatment that can alter bone mineral density
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireFardellone questionnaire (evaluation of calcium intake) Tolerance of treatment | Other | Patients |
Primary outcome
Bone densitometry
Time frame: Day 0
Z score values compared to the reference values
Calcemia
Time frame: Day 0
Blood test
Ionized calcium
Time frame: Day 0
Blood test
Phosphor
Time frame: Day 0
Blood test
Magnesium
Time frame: Day 0
Blood test
Albumin
Time frame: Day 0
Blood test
Parathormone
Time frame: Day 0
Blood test
25 OH vitamin D3
Time frame: Day 0
Blood test
Creatinine
Time frame: Day 0
Blood test
Osteocalcin
Time frame: Day 0
Blood test
Bone alkaline phosphatase isoenzymes
Time frame: Day 0
Blood test
C-terminal telopeptide of type I collagen
Time frame: Day 0
Blood test
Calciuria
Time frame: Day 0
Urine test
Natriuresis
Time frame: Day 0
Urine test
Creatinuria
Time frame: Day 0
Urine test
4 secondary outcomes
Clinical tolerance of treatment
Time frame: Day 0
Follicle stimulating hormone
Time frame: Day 0
Gonadotrophin b LH
Time frame: Day 0
Estradiol
Time frame: Day 0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabrina Da Costa, MD study director
Hôpital Necker-Enfants Malades
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception and Macro-progestins, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone densitometry (time frame: Day 0). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.