AmenorrheaNCT07015476
Retrospective Observational Evaluation of the Bone Mineral Density Outcome in Young Women With Amenorrhea
An observational study of Amenorrhea, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The study aims to evaluate the outcomes of different estrogen therapy regimens in patients with amenorrhea who face prolonged periods of hypoestrogenism. The primary objective is to compare the outcomes on bone mass of different therapeutic regimens and identify more favorable. Read more about this study
- Who is it for?
- Ages 15 to 39 years, women only
- Conditions the study is for
- Amenorrhea
- Type of treatment
- Pill or oral medicine
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 9 Nov 2020to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 to 39 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The present retrospective observational study, monocentric, involves the recruitment of patients who have presented themselves to the U.O. of Gynecology and Pathophysiology of Human Reproduction in the time interval between 2011 and 2020 in condition of amenorrhea above 6 months, Aged between 15 and 39 at the time of first visit. Patients will be asked to participate in this study during the outpatient follow-up visit. The study will involve data collection through consultation of health records.
Who may be able to join
- Patients who have presented themselves to the O.U. of Gynecology and Human Reproduction Pathophysiology in the period from 2011 to 2020 with amenorrhea over 6 months, and aged between 15 and 39 years at the time of the visit.
- Patients who have reached the age of 18 at the time of surgery.
- Patients for whom informed consent has been obtained.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero -Univeristaria di Bologna
Bologna, 40138
Maria C Meriggiola, MD, 0512144394 ext. +39, cristina.meriggiola@unibo.it
About this study
Official title: Retrospective Observational Evaluation of the Bone Mineral Density Outcome of Different Oestrogen Therapy Regimens in Young Women With Amenorrhea
The study aims to evaluate the outcomes of different estrogen therapy regimens in patients with amenorrhea who face prolonged periods of hypoestrogenism.
The primary objective is to compare the outcomes on bone mass of different therapeutic regimens and identify more favorable. For this purpose, densitometry parameters such as BMD, T-score and Z-score at the level of the lumbar spine, femur and entire skeleton will be considered, comparing a bone densitometry (DXA technique, Dual X-ray Absorptiometry) Baseline with one carried out after at least one year of therapy. The secondary objective of the study is to assess other systemic/metabolic implications of the different therapies.
Read the detailed description
The present retrospective monocentric observational study involves the recruitment of patients afferite at the U.O. of Gynecology and Physiopathology of Human Reproduction in the time interval between 2011 and 2020 in condition of amenorrhea greater than 6 months, Aged between 15 and 39 at the time of first visit.
Patients will be asked to participate in this study during the outpatient follow-up visit.
The study will involve data collection through consultation of health records.
The objectives of the study will therefore be achieved by analysing the following parameters, which can be fully deduced from the medical records of the subjects in the study:
- Collection of anamnestic (eating habits and sports, pathologies of note, taking drugs, previous surgical interventions, smoking habit, gynecological history).
- Physical examination: calculation of BMI, acne and hirsutism score (GAGS and Ferriman score), blood pressure measurement, gynecological physical examination
- Transvaginal or transabdominal pelvic ultrasound
- Lumbar, femoral, total body dual-energy x-ray absorptiometry (DXA)
- Blood tests (blood count, lipid profile, glycemic, liver, kidney, hormonal status)
- Reports of other visits and specialist examinations performed by the patients brought to view during the visit
- Conditions
- Amenorrhea
- Keywords
- Amenorrhea, Bone Mass, Estrogen Therapy
- Medical subject headings
- Amenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GROUP A | Natural estrogen (estradiol or valerate estradiol) administered transdermically | |
| GROUP B | Natural estrogen administered orally | |
| GROUP C | Etinil-estradiol administered orally | |
| GROUP D | No therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
The objectives of the study will be achieved by analysing the following parameters:
Collection of anamnestic (eating habits and sports, pathologies of importance, medication intake, previous surgical interventions, smoking habit, gynecological history).
Measured: Until the end of the study (1 year)
Primary Outcome Measure
The objectives of the study will be achieved by analysing the following parameters: Physical examination: calculation of BMI (weight Kg/(height meters * height in meters), blood pressure (mm Hg)
Measured: Until the end of the study (1 year)
Primary Outcome Measure
The objectives of the study will be achieved by analysing the following parameters: Transvaginal or transabdominal pelvic ultrasound (Uterus measures mm; endometrium thickness mm; ovary size volume cc and mesures mm)
Measured: Until the end of the study (1 year)
Primary Outcome Measure
The objectives of the study will be achieved by analysing the following parameters:
Lumbar, femoral, total body dual-energy x-ray absorptiometry (DXA): BMD (g/cm2); T score e Z score.
Measured: Until the end of the study (1 year)
Primary Outcome Measure
Blood tests: hemoglobin (g/gl), hematocrit (%),red blood cells (million/µl), Platelets (x1000/ µl), Glucose (mg/dl), Alt (U/L), Ast (U/L), triglycerides (mg/dl), Total cholesterol (mg/dl), HDL Cholesterol (mg/dl), LH (mU/ml), FSH (mU/ml), Testosteron (ng/ml), Proladctin ( ng/ml), Estradiol (pg/ml); Urinalysis: PH, proteins(mg/dl) Glucose (mg/dl), Red blood cells (num/microL), Leukocytes
Measured: Until the end of the study (1 year)
Secondary outcomes (2)
GAGs and Ferriman Score
For Acne: The GAGS divides the face (forehead, each cheek, nose, and chin), chest, and back into six areas, and the severity in each zone is then assessed on a scale of 0 to 4 (0, no lesions; 1, comedones; 2, papules; 3, pustules; and 4, nodules.
Measured: Until the end of the study (1 year)
GAGs and Ferriman Score
For Hirsutism: The Ferriman-Gallwey is widely used to evaluate and quantify hirsutism in women. The method incorporates nine body regions (excludes legs and forearms) for the assessment of hair growth, rated from 0 (no growth of terminal hair) to 4 (extensive hair growth) in each of the nine locations.
The total score therefore can range from 0 to 36 and a score of > 8 is considered a sign of androgen excess in Caucasian women. A score of 8 -15 indicates mild hirsutism and >15 indicates moderate or severe hirsutism. For other ethnic groups, the amount of hair expected for that ethnicity should be considered.
Measured: Until the end of the study (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start9 Nov 2020
- Primary completionOct 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmenorrheaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Retrospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria C Meriggiola, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015476
- Sponsor's protocol ID
- AMEN-20
- Status last verified
- Nov 2024
- First submitted
- 30 Dec 2024
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Evaluation of the Bone Mineral Density Outcome of Different Oestrogen Therapy Regimens in Young Women With Amenorrhea
- ClinicalTrials.gov ID
- NCT07015476
- Acronym / sponsor ID
- AMEN-20
- Conditions
- Amenorrhea
- Keywords
- Amenorrhea, Bone Mass, Estrogen Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 11 Jun 2025 (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.
The study aims to evaluate the outcomes of different estrogen therapy regimens in patients with amenorrhea who face prolonged periods of hypoestrogenism.
The primary objective is to compare the outcomes on bone mass of different therapeutic regimens and identify more favorable. For this purpose, densitometry parameters such as BMD, T-score and Z-score at the level of the lumbar spine, femur and entire skeleton will be considered, comparing a bone densitometry (DXA technique, Dual X-ray Absorptiometry) Baseline with one carried out after at least one year of therapy. The secondary objective of the study is to assess other systemic/metabolic implications of the different therapies.
Detailed description
The present retrospective monocentric observational study involves the recruitment of patients afferite at the U.O. of Gynecology and Physiopathology of Human Reproduction in the time interval between 2011 and 2020 in condition of amenorrhea greater than 6 months, Aged between 15 and 39 at the time of first visit.
Patients will be asked to participate in this study during the outpatient follow-up visit.
The study will involve data collection through consultation of health records.
The objectives of the study will therefore be achieved by analysing the following parameters, which can be fully deduced from the medical records of the subjects in the study:
- Collection of anamnestic (eating habits and sports, pathologies of note, taking drugs, previous surgical interventions, smoking habit, gynecological history).
- Physical examination: calculation of BMI, acne and hirsutism score (GAGS and Ferriman score), blood pressure measurement, gynecological physical examination
- Transvaginal or transabdominal pelvic ultrasound
- Lumbar, femoral, total body dual-energy x-ray absorptiometry (DXA)
- Blood tests (blood count, lipid profile, glycemic, liver, kidney, hormonal status)
- Reports of other visits and specialist examinations performed by the patients brought to view during the visit
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GROUP A | – | –Natural estrogen (estradiol or valerate estradiol) administered transdermically |
| GROUP B | – | –Natural estrogen administered orally |
| GROUP C | – | –Etinil-estradiol administered orally |
| GROUP D | – | –No therapy |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The present retrospective observational study, monocentric, involves the recruitment of patients who have presented themselves to the U.O. of Gynecology and Pathophysiology of Human Reproduction in the time interval between 2011 and 2020 in condition of amenorrhea above 6 months, Aged between 15 and 39 at the time of first visit. Patients will be asked to participate in this study during the outpatient follow-up visit. The study will involve data collection through consultation of health records.
Key inclusion criteria (3 listed)
- Patients who have presented themselves to the O.U. of Gynecology and Human Reproduction Pathophysiology in the period from 2011 to 2020 with amenorrhea over 6 months, and aged between 15 and 39 years at the time of the visit.
- Patients who have reached the age of 18 at the time of surgery.
- Patients for whom informed consent has been obtained.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Outcome Measure
Time frame: Until the end of the study (1 year)
The objectives of the study will be achieved by analysing the following parameters: Collection of anamnestic (eating habits and sports, pathologies of importance, medication intake, previous surgical interventions, smoking habit, gynecological history).
Primary Outcome Measure
Time frame: Until the end of the study (1 year)
The objectives of the study will be achieved by analysing the following parameters: Physical examination: calculation of BMI (weight Kg/(height meters * height in meters), blood pressure (mm Hg)
Primary Outcome Measure
Time frame: Until the end of the study (1 year)
The objectives of the study will be achieved by analysing the following parameters: Transvaginal or transabdominal pelvic ultrasound (Uterus measures mm; endometrium thickness mm; ovary size volume cc and mesures mm)
Primary Outcome Measure
Time frame: Until the end of the study (1 year)
The objectives of the study will be achieved by analysing the following parameters: Lumbar, femoral, total body dual-energy x-ray absorptiometry (DXA): BMD (g/cm2); T score e Z score.
Primary Outcome Measure
Time frame: Until the end of the study (1 year)
Blood tests: hemoglobin (g/gl), hematocrit (%),red blood cells (million/µl), Platelets (x1000/ µl), Glucose (mg/dl), Alt (U/L), Ast (U/L), triglycerides (mg/dl), Total cholesterol (mg/dl), HDL Cholesterol (mg/dl), LH (mU/ml), FSH (mU/ml), Testosteron (ng/ml), Proladctin ( ng/ml), Estradiol (pg/ml); Urinalysis: PH, proteins(mg/dl) Glucose (mg/dl), Red blood cells (num/microL), Leukocytes
2 secondary outcomes
GAGs and Ferriman Score
Time frame: Until the end of the study (1 year)
GAGs and Ferriman Score
Time frame: Until the end of the study (1 year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Maria C Meriggiola, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Amenorrhea, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 0 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: looking for participants now, as of the sponsor's last update on 11 Jun 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria C Meriggiola, MD (0512144394 ext. +39, cristina.meriggiola@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: Until the end of the study (1 year)). The study lists 5 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 11 Jun 2025.