NCT01087879

Brief Summary

The impact of different administration routes of hormonal contraceptives on androgen secretion, glucose metabolism and inflammation. A prospective randomized trial. The investigators assume, that transdermal or transvaginal hormonal contraception would have less effects on androgen levels, glucose metabolism and inflammatory markers than oral contraceptives.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 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

October 1, 2007

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

September 7, 2011

Status Verified

September 1, 2011

Enrollment Period

3.3 years

First QC Date

March 15, 2010

Last Update Submit

September 6, 2011

Conditions

Contraception

Keywords

oral glucose tolerance testhormonal contraceptionandrogenscrp

Outcome Measures

Primary Outcomes (2)

  • Androgen secretion

    Analysis of androstenedione, testosterone and DHEAS from fasting serum samples.

    0, 5, 9, 10 weeks

  • Protein secretion from liver

    Analysis of SHBG and high sensitivy CRP from fasting serum samples.

    0, 5, 9, 10 weeks

Secondary Outcomes (1)

  • Glucose metabolism

    0, (5), 9, (10) weeks

Study Arms (3)

Oral contraceptive pill

ACTIVE COMPARATOR

9 weeks treatment with contraceptive pill.

Drug: Desogestrel-Ethinyl Estradiol contraceptive pill

Contraception vaginal ring

ACTIVE COMPARATOR

9 weeks treatment with vaginal ring.

Drug: Etonogestrel-Ethinyl Estradiol vaginal ring

Transdermal contraceptive patch

ACTIVE COMPARATOR

9 weeks treatment with a transdermal contraceptive patch.

Drug: Norelgestromin-Ethinyl Estradiol contraceptive patch

Interventions

Desogestrel-Ethinyl Estradiol contraceptive pillDRUG

150 microg Desogestrel and 20 microg Ethinyl Estradiol combination. One pill once a day for 9 weeks, continual administration.

Also known as: Mercilon
Oral contraceptive pill
Etonogestrel-Ethinyl Estradiol vaginal ringDRUG

Etonogestrel-Ethinyl Estradiol vaginal ring, which consists of 11,7 mg etonogestrel and 2,7 mg ethinyl estradiol. It delivers 0,120 mg etonogestrel and 0,015 mg ethinyl estradiol per day. Treatment continues continual for 9 weeks and the vaginal ring is changed every three weeks.

Also known as: NuvaRing
Contraception vaginal ring
Norelgestromin-Ethinyl Estradiol contraceptive patchDRUG

A combination transdermal contraceptive patch with 6 mg of norelgestromin and 600 microg of ethinyl estradiol. It delivers 203 microg of norelgestromin and 33,9 microg ethinyl estradiol per day. A continual use of patch for 9 weeks and the patch is changed every week.

Also known as: Evra
Transdermal contraceptive patch

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy women aged from 20 to 35 years
  • regular menstruation
  • no use of hormonal contraception or two months wash-out period
  • no contraindications for using hormonal contraception

You may not qualify if:

  • irregular menstruation
  • smoking
  • alcohol addiction
  • pregnancy or nursing
  • hypersensitivity to any components of the products
  • headaches with focal neurological symptoms
  • serious or multiple risk factors for artery disease
  • undiagnosed abnormal genital bleeding
  • impaired glucose tolerance or DM-T2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynaecology, University of Oulu

Oulu, 90014, Finland

Location

Related Publications (2)

  • Kallio S, Puurunen J, Ruokonen A, Vaskivuo T, Piltonen T, Tapanainen JS. Antimullerian hormone levels decrease in women using combined contraception independently of administration route. Fertil Steril. 2013 Apr;99(5):1305-10. doi: 10.1016/j.fertnstert.2012.11.034. Epub 2012 Dec 20.

    PMID: 23260855DERIVED

  • Piltonen T, Puurunen J, Hedberg P, Ruokonen A, Mutt SJ, Herzig KH, Nissinen A, Morin-Papunen L, Tapanainen JS. Oral, transdermal and vaginal combined contraceptives induce an increase in markers of chronic inflammation and impair insulin sensitivity in young healthy normal-weight women: a randomized study. Hum Reprod. 2012 Oct;27(10):3046-56. doi: 10.1093/humrep/des225. Epub 2012 Jul 18.

    PMID: 22811306DERIVED

MeSH Terms

Interventions

ethinyl estradiol-desogestrel combinationNuvaRingOrtho Evra

Study Officials

  • Juha S. Tapanainen, Professor

    Dept Ob-Gyn, University of Oulu

    STUDY CHAIR

  • Terhi T. Piltonen, MD

    Dept Ob-Gyn, University of Oulu

    STUDY DIRECTOR

  • Johanna M. Puurunen, MD

    Dept Ob-Gyn, Univeristy of Oulu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 15, 2010

First Posted

March 16, 2010

Study Start

October 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

September 7, 2011

Record last verified: 2011-09

Locations

FI(1)