ContraceptionNCT01087879
The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism
A study testing Desogestrel-Ethinyl Estradiol contraceptive pill, Etonogestrel-Ethinyl Estradiol vaginal ring and Norelgestromin-Ethinyl Estradiol contraceptive patch in people with Contraception, run by University of Oulu at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Desogestrel-Ethinyl Estradiol contraceptive pill, Etonogestrel-Ethinyl Estradiol vaginal ring and Norelgestromin-Ethinyl Estradiol contraceptive patch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2007to Jan 2011
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- irregular menstruation
- smoking
- alcohol addiction
- pregnancy or nursing
- hypersensitivity to any components of the products
- headaches with focal neurological symptoms
Show all 9Show fewer
- serious or multiple risk factors for artery disease
- undiagnosed abnormal genital bleeding
- impaired glucose tolerance or DM-T2
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Obstetrics and Gynaecology, University of Oulu
Oulu, 90014
About this study
Official title: The Impact of Different Administration Routes of Hormonal Contraceptives on Androgen Synthesis, Glucose Metabolism and Inflammation. A Prospective Randomized Trial.
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.
Read the detailed description
45 patients are recruited in the study. Each study group will consist of 15 women (aged 20-35 years) receiving oral, transdermal or transvaginal hormonal contraception continuously for 9 weeks. The subjects should have at least 2 months wash out period from all hormonal medication prior to the study.
The measurements for serum sampling and OGTT will be performed before and after 9 weeks of medication.
- Conditions
- Contraception
- Being tested
- Desogestrel-Ethinyl Estradiol contraceptive pill, Etonogestrel-Ethinyl Estradiol vaginal ring, Norelgestromin-Ethinyl Estradiol contraceptive patch
- Keywords
- oral glucose tolerance test, hormonal contraception, androgens, crp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desogestrel-Ethinyl Estradiol contraceptive pillDrug
Also called Mercilon
150 microg Desogestrel and 20 microg Ethinyl Estradiol combination. One pill once a day for 9 weeks, continual administration.
Etonogestrel-Ethinyl Estradiol vaginal ringDrug
Also called NuvaRing
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.
Norelgestromin-Ethinyl Estradiol contraceptive patchDrug
Also called Evra
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral contraceptive pill | Active comparator | 9 weeks treatment with contraceptive pill. Receives: Drug: Desogestrel-Ethinyl Estradiol contraceptive pill |
| Contraception vaginal ring | Active comparator | 9 weeks treatment with vaginal ring. Receives: Drug: Etonogestrel-Ethinyl Estradiol vaginal ring |
| Transdermal contraceptive patch | Active comparator | 9 weeks treatment with a transdermal contraceptive patch. Receives: Drug: Norelgestromin-Ethinyl Estradiol contraceptive patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Androgen secretion
Analysis of androstenedione, testosterone and DHEAS from fasting serum samples.
Measured: 0, 5, 9, 10 weeks
Protein secretion from liver
Analysis of SHBG and high sensitivy CRP from fasting serum samples.
Measured: 0, 5, 9, 10 weeks
Secondary outcomes (1)
Glucose metabolism
Oral glucose tolerance test at 0 and 9 weeks. Fasting glucose, insulin and c-peptid at 5 and 10 weeks.
Measured: 0, (5), 9, (10) weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startOct 2007
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Investigators
- Juha S. Tapanainen, Professor, Study chair, Dept Ob-Gyn, University of OuluTerhi T. Piltonen, MD, Study director, Dept Ob-Gyn, University of OuluJohanna M. Puurunen, MD, Principal investigator, Dept Ob-Gyn, Univeristy of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087879
- Sponsor's protocol ID
- 191/2006
- Status last verified
- Sep 2011
- First submitted
- 15 Mar 2010
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23260855Piltonen 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.
PubMed 22811306
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Administration Routes of Hormonal Contraceptives on Androgen Synthesis, Glucose Metabolism and Inflammation. A Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT01087879
- Acronym / sponsor ID
- 191/2006
- Conditions
- Contraception
- Keywords
- oral glucose tolerance test, hormonal contraception, androgens, crp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 Mar 2010 (estimated)
- 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.
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.
Detailed description
45 patients are recruited in the study. Each study group will consist of 15 women (aged 20-35 years) receiving oral, transdermal or transvaginal hormonal contraception continuously for 9 weeks. The subjects should have at least 2 months wash out period from all hormonal medication prior to the study.
The measurements for serum sampling and OGTT will be performed before and after 9 weeks of medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral contraceptive pill | Active comparator | Drug: Desogestrel-Ethinyl Estradiol contraceptive pill9 weeks treatment with contraceptive pill. |
| Contraception vaginal ring | Active comparator | Drug: Etonogestrel-Ethinyl Estradiol vaginal ring9 weeks treatment with vaginal ring. |
| Transdermal contraceptive patch | Active comparator | Drug: Norelgestromin-Ethinyl Estradiol contraceptive patch9 weeks treatment with a transdermal contraceptive patch. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- irregular menstruation
- smoking
- alcohol addiction
- pregnancy or nursing
- hypersensitivity to any components of the products
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 |
|---|---|---|
| Desogestrel-Ethinyl Estradiol contraceptive pillAlso: Mercilon150 microg Desogestrel and 20 microg Ethinyl Estradiol combination. One pill once a day for 9 weeks, continual administration. | Drug | Oral contraceptive pill |
| Etonogestrel-Ethinyl Estradiol vaginal ringAlso: NuvaRingEtonogestrel-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. | Drug | Contraception vaginal ring |
| Norelgestromin-Ethinyl Estradiol contraceptive patchAlso: EvraA 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. | Drug | Transdermal contraceptive patch |
Primary outcome
Androgen secretion
Time frame: 0, 5, 9, 10 weeks
Analysis of androstenedione, testosterone and DHEAS from fasting serum samples.
Protein secretion from liver
Time frame: 0, 5, 9, 10 weeks
Analysis of SHBG and high sensitivy CRP from fasting serum samples.
1 secondary outcome
Glucose metabolism
Time frame: 0, (5), 9, (10) weeks
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 7 Sep 2011.
- Derived from this study: PubMed 23260855Kallio 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.
- Derived from this study: PubMed 22811306Piltonen 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.
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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.
Juha S. Tapanainen, Professor study chair
Dept Ob-Gyn, University of Oulu
Terhi T. Piltonen, MD study director
Dept Ob-Gyn, University of Oulu
Johanna M. Puurunen, MD principal investigator
Dept Ob-Gyn, Univeristy of Oulu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desogestrel-Ethinyl Estradiol contraceptive pill, Etonogestrel-Ethinyl Estradiol vaginal ring and Norelgestromin-Ethinyl Estradiol contraceptive patch in people with Contraception, run by University of Oulu at 1 site in Finland.
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 4 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 7 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Androgen secretion (time frame: 0, 5, 9, 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01087879, which also lists 2 linked publications.
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 7 Sep 2011.