NCT03064412

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
Last Updated

July 24, 2017

Status Verified

July 1, 2017

Enrollment Period

2.3 years

First QC Date

February 22, 2017

Last Update Submit

July 20, 2017

Conditions

Sex Steroids

Outcome Measures

Primary Outcomes (1)

  • Changes in sex steroids

    Changes to levels of sex steroids throughout pregnancy and after delivery

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

Interventions

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.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Howard Berger, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2017

First Posted

February 27, 2017

Study Start

September 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

July 24, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share