Hypothalamic AmenorrheaNCT02984696
Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea
A study testing 1 mg of transdermal estradiol daily and 10mg of oral MPA in people with Hypothalamic Amenorrhea, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
The aim of our study is to investigate the effects of 6 months oh HRT on total anti-oxidant capacity, clinical, endocrine and metabolic features in women affected by hypotalamic amenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Hypothalamic Amenorrhea
- What is being tested?
- 1 mg of transdermal estradiol daily and 10mg of oral MPA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2015to Dec 2017
- Phase
- Interventional
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Hypotalamic Amenorrhea
Who cannot join
- diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)
- hypertension
- significant liver or renal impairment
- other hormonal dysfunction (hypothalamic, pituitary, PCOS, thiroidal or adrenal)
- neoplasms
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Catholic university of Sacred Heart
Rome, Rome, 00168
Rosanna Apa, MD, krimisa@libero.it
Rosanna Apa, MD
About this study
Official title: Effects of 6 Months of HRT on Total Antioxidant Capacity in Patients Affected by Hypotalamic Amenorrhea
The aim of our study is to investigate the effects of 6 months oh HRT on total anti-oxidant capacity, clinical, endocrine and metabolic features in women affected by hypotalamic amenorrhea. The study group included 20 patients treated with 1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months. Menstrual pattern, anthropometric parameters, hormonal assays, DXA and bone metabolism parameters are evaluated before and after therapy.
- Conditions
- Hypothalamic Amenorrhea
- Being tested
- 1 mg of transdermal estradiol daily and 10mg of oral MPA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 mg of transdermal estradiol daily and 10mg of oral MPADrug
| Study group | Role | What they receive |
|---|---|---|
| Hormonal Replace Therapy | Experimental | 1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months Receives: Drug: 1 mg of transdermal estradiol daily and 10mg of oral MPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Anti-oxidant Capacity
Measured: 6 Month
Secondary outcomes (5)
Bone Mineral Density
Measured: 6 Months
Osteocalcin
Measured: 6 Months
Estrogen levels
Measured: 6 Months
number of Cycles in 6 months
n° of menstrual cycle
Measured: 6 Months
beta crosslaps
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startMar 2015
- Primary completionOct 2016
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothalamic AmenorrheaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosanna Apa, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984696
- Sponsor's protocol ID
- Hypotalamic Amenorrhea-01
- Status last verified
- Dec 2016
- First submitted
- 5 Mar 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 6 Months of HRT on Total Antioxidant Capacity in Patients Affected by Hypotalamic Amenorrhea
- ClinicalTrials.gov ID
- NCT02984696
- Acronym / sponsor ID
- Hypotalamic Amenorrhea-01
- Conditions
- Hypothalamic Amenorrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 7 Dec 2016 (estimated)
- 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 aim of our study is to investigate the effects of 6 months oh HRT on total anti-oxidant capacity, clinical, endocrine and metabolic features in women affected by hypotalamic amenorrhea. The study group included 20 patients treated with 1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months. Menstrual pattern, anthropometric parameters, hormonal assays, DXA and bone metabolism parameters are evaluated before and after therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hormonal Replace Therapy | Experimental | Drug: 1 mg of transdermal estradiol daily and 10mg of oral MPA1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Hypotalamic Amenorrhea
Key exclusion criteria (5 listed)
- diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)
- hypertension
- significant liver or renal impairment
- other hormonal dysfunction (hypothalamic, pituitary, PCOS, thiroidal or adrenal)
- neoplasms
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 |
|---|---|---|
| 1 mg of transdermal estradiol daily and 10mg of oral MPA | Drug | Hormonal Replace Therapy |
Primary outcome
Total Anti-oxidant Capacity
Time frame: 6 Month
5 secondary outcomes
Bone Mineral Density
Time frame: 6 Months
Osteocalcin
Time frame: 6 Months
Estrogen levels
Time frame: 6 Months
number of Cycles in 6 months
Time frame: 6 Months
beta crosslaps
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 mg of transdermal estradiol daily and 10mg of oral MPA in people with Hypothalamic Amenorrhea, run by Catholic University of the Sacred Heart 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Dec 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Anti-oxidant Capacity (time frame: 6 Month). 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 7 Dec 2016.