NCT02654548

Brief Summary

To investigate whether women with polycystic ovary syndrome who are post-partum excrete higher levels of sebum in comparison to healthy controls due to high levels of androgens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

2.7 years

First QC Date

January 11, 2016

Last Update Submit

August 20, 2019

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Sebum output using Sebutape

    18 months

Study Arms (2)

PCOS women and babies

EXPERIMENTAL

Sebum output using Sebutape on post-partum PCOS women and new born babies.

Other: Sebutape

Non-PCOS women and babies

ACTIVE COMPARATOR

Sebum output using Sebutape on post-partum non-PCOS women and new born babies.

Other: Sebutape

Interventions

SebutapeOTHER

Women who consent to the study will have a sebutape attached to their and their babies foreheads to measure the levels of androgens.

Non-PCOS women and babiesPCOS women and babies

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • baby boys

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Homerton Fertility Centre

London, E9 6SR, United Kingdom

Location

Related Publications (1)

  • Homburg R, Gudi A, Shah A, M Layton A. A novel method to demonstrate that pregnant women with polycystic ovary syndrome hyper-expose their fetus to androgens as a possible stepping stone for the developmental theory of PCOS. A pilot study. Reprod Biol Endocrinol. 2017 Aug 8;15(1):61. doi: 10.1186/s12958-017-0282-1.

    PMID: 28789693DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Roy Homburg, FROG

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 13, 2016

Study Start

June 1, 2013

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

August 22, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)