Sex SteroidsNCT03064412
Effect of Pregnancy on Androgenic Steroids in Different Genetic Panels
A study testing Urine sample collection and Saliva collection in people with Sex Steroids, run by Unity Health Toronto.
Trial summary
Androgens are important sex steroids in women. Androgens influence protein synthesis and muscle growth, are involved in maturation of the reproductive organs, have a fat reducing effect , have a negative effect on the serum lipid profile, and may also increase insulin resistance and coagulation activity. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sex Steroids
- What is being tested?
- Urine sample collection and Saliva collection
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jan 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy women without drug treatment, in the age range of 18-40 years
Who cannot join
- Any chronic disease such as Hypertension or Diabetes Mellitus
- Positive for HIV, hepatitis, Syphilis
- Abnormal laboratory test results (e.g. abnormal TSH, glucose, creatinine, HIV, HBV, VDRL)
- PCOS
- Ongoing hormonal treatment-e.g. progesterone, estrogen or other
- Smoking cigarettes, alcohol, regular substance use
Show all 9Show fewer
- Confirmed or suspected abuse of drugs
- Chronic prescription drugs
- Pre-existing diabetes or GDM in last pregnancy
About this study
Androgens are important sex steroids in women. Androgens influence protein synthesis and muscle growth, are involved in maturation of the reproductive organs, have a fat reducing effect , have a negative effect on the serum lipid profile, and may also increase insulin resistance and coagulation activity. The role of androgens in women is not clear. This study is aimed at learning about the amount of androgen and its actions in pregnant women. This study is also looking to see if there are specific patient factors (such as genetics) that change the amount of androgen and its activity.
Read the detailed description
There is a lot of information about the main female sex hormones such as estrogens and progesterones (the main female sex hormones and the most important in menstrual , reproductive cycles and pregnancy) . However there is little information about androgens in pregnant women. It is known that certain illnesses, chemicals and dietary products might change the amount of androgen and its actions, which could affect the mother and her baby. It is also known that there are differences between the androgen levels in different people, and in different ethnic groups. These differences are mostly due to genetic factors. The goal of this study is to learn about the androgen levels in healthy pregnant women and if genetic or clinical factors (for example age, trimester of pregnancy, parity, ethnicity, etc.) play a role in changing the androgen amount and action, throughout pregnancy and after delivery.
- Conditions
- Sex Steroids
- Being tested
- Urine sample collection, Saliva collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine sample collectionBiological
A urine sample will be collected in each of the 3 trimesters of pregnancy, and also at 6 weeks post partum.
Saliva collectionBiological
A saliva sample will be collected at one time point during the study - likely at the initial baseline visit.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in sex steroids
Changes to levels of sex steroids throughout pregnancy and after delivery
Measured: 1st trimester (1-12 weeks gestation), 2nd trimester (13-28 weeks gestation), 3rd trimester (28-40 weeks gestation), 6 weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study startSep 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sex SteroidsStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard Berger, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064412
- Sponsor's protocol ID
- 14-145
- Status last verified
- Jul 2017
- First submitted
- 22 Feb 2017
- Last updated
- 24 Jul 2017
- 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 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pregnancy on Androgenic Steroids in Different Genetic Panels
- ClinicalTrials.gov ID
- NCT03064412
- Acronym / sponsor ID
- 14-145
- Conditions
- Sex Steroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 27 Feb 2017 (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.
Androgens are important sex steroids in women. Androgens influence protein synthesis and muscle growth, are involved in maturation of the reproductive organs, have a fat reducing effect , have a negative effect on the serum lipid profile, and may also increase insulin resistance and coagulation activity. The role of androgens in women is not clear. This study is aimed at learning about the amount of androgen and its actions in pregnant women. This study is also looking to see if there are specific patient factors (such as genetics) that change the amount of androgen and its activity.
Detailed description
There is a lot of information about the main female sex hormones such as estrogens and progesterones (the main female sex hormones and the most important in menstrual , reproductive cycles and pregnancy) . However there is little information about androgens in pregnant women. It is known that certain illnesses, chemicals and dietary products might change the amount of androgen and its actions, which could affect the mother and her baby. It is also known that there are differences between the androgen levels in different people, and in different ethnic groups. These differences are mostly due to genetic factors. The goal of this study is to learn about the androgen levels in healthy pregnant women and if genetic or clinical factors (for example age, trimester of pregnancy, parity, ethnicity, etc.) play a role in changing the androgen amount and action, throughout pregnancy and after delivery.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy women without drug treatment, in the age range of 18-40 years
Key exclusion criteria (9 listed)
- Any chronic disease such as Hypertension or Diabetes Mellitus
- Positive for HIV, hepatitis, Syphilis
- Abnormal laboratory test results (e.g. abnormal TSH, glucose, creatinine, HIV, HBV, VDRL)
- PCOS
- Ongoing hormonal treatment-e.g. progesterone, estrogen or other
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 |
|---|---|---|
| Urine sample collectionA urine sample will be collected in each of the 3 trimesters of pregnancy, and also at 6 weeks post partum. | Biological | – |
| Saliva collectionA saliva sample will be collected at one time point during the study - likely at the initial baseline visit. | Biological | – |
Primary outcome
Changes in sex steroids
Time frame: 1st trimester (1-12 weeks gestation), 2nd trimester (13-28 weeks gestation), 3rd trimester (28-40 weeks gestation), 6 weeks post-partum
Changes to levels of sex steroids throughout pregnancy and after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- 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. This study is not recruiting at the moment.
Howard Berger, MD principal investigator
Unity Health Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Urine sample collection and Saliva collection in people with Sex Steroids, run by Unity Health Toronto.
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 9 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: finished, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in sex steroids (time frame: 1st trimester (1-12 weeks gestation), 2nd trimester (13-28 weeks gestation), 3rd trimester (28-40 weeks gestation), 6 weeks post-partum). 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 24 Jul 2017.