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CompletedNCT03064412Updated Jul 24, 2017

Effect of Pregnancy on Androgenic Steroids in Different Genetic Panels

An interventional study of Urine sample collection and Saliva collection in Sex Steroids, sponsored by Unity Health Toronto. Completed. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-24.

Sponsored by Unity Health Toronto · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Sep 2014, registered Feb 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Sex Steroids
03

In context

Lead sponsor

Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy women without drug treatment, in the age range of 18-40 years

Exclusion criteria

Exclusion Criteria:

  • 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
  • Confirmed or suspected abuse of drugs
  • Chronic prescription drugs
  • Pre-existing diabetes or GDM in last pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (actual)

Interventions

  • BiologicalUrine sample collection

    A urine sample will be collected in each of the 3 trimesters of pregnancy, and also at 6 weeks post partum.

  • BiologicalSaliva collection

    A saliva sample will be collected at one time point during the study - likely at the initial baseline visit.

06

What researchers measure

Primary outcomes

  1. Changes in sex steroids

    Changes to levels of sex steroids throughout pregnancy and after delivery

    Time frame: 1st trimester (1-12 weeks gestation), 2nd trimester (13-28 weeks gestation), 3rd trimester (28-40 weeks gestation), 6 weeks post-partum

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03064412
Lead sponsor
Unity Health Toronto
Responsible party
Sponsor
First posted
Feb 27, 2017
Start date
Sep 2014
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Jul 24, 2017

Study contacts

Howard Berger, MD
principal investigator · Unity Health Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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