ContraceptionPhase 4NCT01044056

A Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30) (Study 34237 (P06650)) (COMPLETED)

A Phase 4 study testing Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets, norelgestrominum and ethinylestradiol patch oral contraceptive patch and Nuvaring ™ (etonorgestrel/ethinylestradiol) in people with Contraception, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

An open-label, randomized, parallel group trial in healthy female subjects to compare the pharmacokinetics of ethinyl estradiol (EE) of NuvaRing®, a contraceptive patch (EVRA(TM)) and an oral contraceptive (Microgynon® 30). Read more about this study

Who is it for?: Ages 18 to 40 years, women only
Conditions the study is for: Contraception
What is being tested?: Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets, norelgestrominum and ethinylestradiol patch oral contraceptive patch and Nuvaring ™ (etonorgestrel/ethinylestradiol)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: Mar 2004to Jun 2004
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 40 years
Women only
No healthy volunteers
Adult

Who may be able to join

Subject is at least 18 but not older than 40 years of age on Day 1 of treatment.
Subject has uterus and ovaria in situ
Subject who does not use hormonal contraception and is willing to use adequate nonhormonal contraceptive measures during the timeframe between screening and start treatment.
Subject is able and willing to refrain from caffeine and/or xanthine containing food and/or beverages (e.g. coffee, tea, cola or chocolate) from 24 hours before the first administration of the trial medication until the last PK blood sample.
Subject is willing not to consume grapefruit containing products 14 days prior to the start of the first administration of the trial medication until the last PK blood sample.
Subject is willing to refrain from smoking from 7 days prior to first administration of the trial medication until the last pharmacokinetic blood sample.
Subject is willing to refrain from alcohol containing products from 24 hours prior to first administration of the trial medication until the last pharmacokinetic blood sample.

Who cannot join

Contraindications for use of NuvaRing, contraceptive patch and oral contraceptive:
Presence or history of venous thrombosis, with or without the involvement of pulmonary embolism.
Presence or history of arterial thrombosis (e.g. cerebrovascular accident, myocardial infarction) or prodromi of a thrombosis (e.g. angina pectoris or transient ischaemic attack).
Known predisposition for venous or arterial thrombosis, with or without hereditary involvement such as Activated Protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant) and Factor V Leiden mutation.
Diabetes mellitus with vascular involvement
The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (to be judged by the (sub-) investigator

Show all 26Show fewer

Presence or history of severe hepatic disease as long as liver function values had not returned to normal or were judged to be clinically significant by the investigator.
Presence or history of liver tumours (benign or malignant).
Known or suspected malignant conditions of the genital organs or the breasts, if sex-steroid-influenced.
Undiagnosed vaginal bleeding.
Hypersensitivity to the active substances or to any of the excipients of NuvaRing, contraceptive patch and oral contraceptive.
Migraine with focal aura
Known or suspected pregnancy
Breastfeeding, or within 2 months after stopping breastfeeding on the day preceding the first administration of trial medication (Day -1).
Clinically significant abnormal laboratory, ECG (electrocardiogram) vital signs, physical and gynecological findings at screening.
A significant (history of) allergic or other serious disease, particularly gastrointestinal tract disease.
Smoking more than 5 cigarettes or 1 pipe or 1 cigar per day for a period of at least 3 months prior to screening.
Using any systemic medication (including over the counter (OTC) medication) during the 14 days prior to the day preceding the first administration of trial medication (Day -1), except for oral contraceptive used for synchronization and occasional Ibuprofen.
Used any drug or substance that is known to induce drug-metabolizing enzymes within two months prior to the start of synchronization.
Received a contraceptive by injection, an implant or hormonal intra-uterine device within 6 months of the day preceding the first administration of trial medication (Day -1), or a hormonal implant or hormonal intra-uterine device removed within 6 months of the day preceding the first administration of trial medication (Day -1).
Participated in a drug trial and was administered an investigational drug during the 90 days prior to start of synchronization.
Donated blood during the 90 days prior to the day preceding the first administration of trial medication (Day -1).
History (within the last 2 years) of excessive alcohol use, use of solvents or of drug abuse.
Positive drug test at screening and/or admission (Day -1), or a positive alcohol test at admission (Day -1).
Clinically significant abnormal cervical smear result (papaninecolaou (PAP) III or higher) at screening.
Acute or chronic hepatitis B/C or human immune deficiency virus (HIV) 1\&2 infection.

About this study

Official title: An Open-label, Randomized, Parallel Group Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30)

Conditions: Contraception
Being tested: Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets, norelgestrominum and ethinylestradiol patch oral contraceptive patch, Nuvaring ™ (etonorgestrel/ethinylestradiol)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tabletsDrug
Also called Microgynon, Batch Number: 374A 01K05
LNG/EE oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
norelgestrominum and ethinylestradiol patch oral contraceptive patchDrug
Also called EVRA ™, Batch number : 0311264
A contraceptive patch (EVRA ™), one patch for 7 days for three consecutive weeks, 3 patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
Nuvaring ™ (etonorgestrel/ethinylestradiol)Drug
NuvaRing ™ , one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.

Study groups in NCT01044056
Study group	Role	What they receive
Levonorgestrel/ethinylestradiol oral contraceptive pill	Active comparator	Microgynon(R), 1 tablet every day for 21 days; each tablet contains 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE). Receives: Drug: Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets
Norelgestrominum and ethinylestradiol contraceptive patch	Active comparator	Evra(TM), One patch applied on lower abdomen for 7 days for 3 consecutive weeks, 3 patches in total. Each patch contains 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day. Receives: Drug: norelgestrominum and ethinylestradiol patch oral contraceptive patch
Etonogestrel and ethinylestradiol contraceptive vaginal ring	Active comparator	Nuvaring(R), Place the ring in the vagina for 21 days, remove for one week. Repeat with new Ring. Dose: per ring 11.7 mg ENG and 2.7 mg EE releasing a daily average amount of 0.120 mg ENG and 0.015 mg EE. Receives: Drug: Nuvaring ™ (etonorgestrel/ethinylestradiol)

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Concentration (Cmax) (Pharmacokinentic Parameter (PK)) for All Subjects in the Pharmacokinetically Evaluable (ASPE) Group
Cmax was measured using ethinylstradiol serum concentration at several time points during the 21 days of active treatment and the washout thereafter.
Measured: 21 days of active treatment and washout period thereafter
Area Under the Curve (AUC) 0-21 Days (PK Parameter) Measured for the ASPE Group
AUC 0-21 days was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment
Measured: 21 days
AUC 0-tlast (PK Parameter) for the ASPE Group.
AUC 0-tlast was measured using ethinylestradiol serum concentrations using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter.
Measured: 21 days of active treatment and washout period thereafter
AUC 0-infinity (PK Parameter) for the ASPE Group.
AUC 0-infinity was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter. AUC 0-infinity was calculated as AUC 0-tlast extrapolated to infinity using the regression line from which t 1/2 was calculated.
Measured: 21 days of active treatment and the washout period thereafter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2004Jun 2004

First posted7 Jan 2010 (estimated)
Study startMar 2004
Primary completionJun 2004
Study completionJun 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)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 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01044056
Sponsor's protocol ID: P06650
Status last verified: Feb 2022
First submitted: 5 Jan 2010
Last updated: 4 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

van den Heuvel MW, van Bragt AJ, Alnabawy AK, Kaptein MC. Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive. Contraception. 2005 Sep;72(3):168-74. doi: 10.1016/j.contraception.2005.03.005.
PubMed 16102549

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized, Parallel Group Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30)
ClinicalTrials.gov ID: NCT01044056
Acronym / sponsor ID: P06650
Conditions: Contraception
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Mar 2004
Primary completion: Jun 2004 (actual)
Study completion: Jun 2004 (actual)
First posted: 7 Jan 2010 (estimated)
Results: Posted 31 Mar 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Levonorgestrel/ethinylestradiol oral contraceptive pill	Active comparator	Drug: Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tabletsMicrogynon(R), 1 tablet every day for 21 days; each tablet contains 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE).
Norelgestrominum and ethinylestradiol contraceptive patch	Active comparator	Drug: norelgestrominum and ethinylestradiol patch oral contraceptive patchEvra(TM), One patch applied on lower abdomen for 7 days for 3 consecutive weeks, 3 patches in total. Each patch contains 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
Etonogestrel and ethinylestradiol contraceptive vaginal ring	Active comparator	Drug: Nuvaring ™ (etonorgestrel/ethinylestradiol)Nuvaring(R), Place the ring in the vagina for 21 days, remove for one week. Repeat with new Ring. Dose: per ring 11.7 mg ENG and 2.7 mg EE releasing a daily average amount of 0.120 mg ENG and 0.015 mg EE.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Subject is at least 18 but not older than 40 years of age on Day 1 of treatment.
Subject has uterus and ovaria in situ
Subject who does not use hormonal contraception and is willing to use adequate nonhormonal contraceptive measures during the timeframe between screening and start treatment.
Subject is able and willing to refrain from caffeine and/or xanthine containing food and/or beverages (e.g. coffee, tea, cola or chocolate) from 24 hours before the first administration of the trial medication until the last PK blood sample.
Subject is willing not to consume grapefruit containing products 14 days prior to the start of the first administration of the trial medication until the last PK blood sample.

Key exclusion criteria (26 listed)

Contraindications for use of NuvaRing, contraceptive patch and oral contraceptive:
Presence or history of venous thrombosis, with or without the involvement of pulmonary embolism.
Presence or history of arterial thrombosis (e.g. cerebrovascular accident, myocardial infarction) or prodromi of a thrombosis (e.g. angina pectoris or transient ischaemic attack).
Known predisposition for venous or arterial thrombosis, with or without hereditary involvement such as Activated Protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant) and Factor V Leiden mutation.
Diabetes mellitus with vascular involvement

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
Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tabletsAlso: Microgynon, Batch Number: 374A 01K05LNG/EE oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.	Drug	Levonorgestrel/ethinylestradiol oral contraceptive pill
norelgestrominum and ethinylestradiol patch oral contraceptive patchAlso: EVRA ™, Batch number : 0311264A contraceptive patch (EVRA ™), one patch for 7 days for three consecutive weeks, 3 patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.	Drug	Norelgestrominum and ethinylestradiol contraceptive patch
Nuvaring ™ (etonorgestrel/ethinylestradiol)NuvaRing ™ , one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.	Drug	Etonogestrel and ethinylestradiol contraceptive vaginal ring

Primary outcome

Maximum Concentration (Cmax) (Pharmacokinentic Parameter (PK)) for All Subjects in the Pharmacokinetically Evaluable (ASPE) Group
Time frame: 21 days of active treatment and washout period thereafter
Cmax was measured using ethinylstradiol serum concentration at several time points during the 21 days of active treatment and the washout thereafter.
Area Under the Curve (AUC) 0-21 Days (PK Parameter) Measured for the ASPE Group
Time frame: 21 days
AUC 0-21 days was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment
AUC 0-tlast (PK Parameter) for the ASPE Group.
Time frame: 21 days of active treatment and washout period thereafter
AUC 0-tlast was measured using ethinylestradiol serum concentrations using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter.
AUC 0-infinity (PK Parameter) for the ASPE Group.
Time frame: 21 days of active treatment and the washout period thereafter
AUC 0-infinity was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter. AUC 0-infinity was calculated as AUC 0-tlast extrapolated to infinity using the regression line from which t 1/2 was calculated.

Results and safety

Results posted to the registry on 31 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill	8	8
Norelgestrominum and Ethinylestradiol Contraceptive Patch	8	8
Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring	8	8

Primary outcome: Maximum Concentration (Cmax) (Pharmacokinentic Parameter (PK)) for All Subjects in the Pharmacokinetically Evaluable (ASPE) Group

Time frame: 21 days of active treatment and washout period thereafter. Mean (Standard Deviation). Unit: pg/ml

Measure	Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill n = 8	Norelgestrominum and Ethinylestradiol Contraceptive Patch n = 6	Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring n = 8
Value	168 (29.5)	105 (12.4)	37.1 (5.1)

Population analysed: Subjects who received at least one dose of medication

Primary outcome: Area Under the Curve (AUC) 0-21 Days (PK Parameter) Measured for the ASPE Group

Time frame: 21 days. Mean (Standard Deviation). Unit: nh.h/mL

Measure	Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill n = 8	Norelgestrominum and Ethinylestradiol Contraceptive Patch n = 6	Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring n = 8
Value	21.9 (2.9)	35.8 (5.5)	10.6 (2.5)

Population analysed: Subjects who received at least one dose of medication.

Primary outcome: AUC 0-tlast (PK Parameter) for the ASPE Group.

Time frame: 21 days of active treatment and washout period thereafter. Mean (Standard Deviation). Unit: ng.h/mL

Measure	Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill n = 8	Norelgestrominum and Ethinylestradiol Contraceptive Patch n = 6	Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring n = 8
Value	22.5 (2.9)	37.5 (5.7)	11.1 (2.7)

Population analysed: Subjects who received at least one dose of medication.

Primary outcome: AUC 0-infinity (PK Parameter) for the ASPE Group.

Time frame: 21 days of active treatment and the washout period thereafter. Mean (Standard Deviation). Unit: ng.h/mL

Measure	Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill n = 8	Norelgestrominum and Ethinylestradiol Contraceptive Patch n = 6	Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring n = 8
Value	22.7 (2.8)	37.7 (5.6)	11.2 (2.7)

Adverse events

Time frame: 21 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Levonorgestrel/Ethinylestradiol Oral Contraceptive Tablets	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
Norelgestrominum and Ethinylestradiol Contraceptive Patch	0 of 8 (0%)	8 of 8 (100%)	Not reported
Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring	0 of 8 (0%)	8 of 8 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 16102549van den Heuvel MW, van Bragt AJ, Alnabawy AK, Kaptein MC. Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive. Contraception. 2005 Sep;72(3):168-74. doi: 10.1016/j.contraception.2005.03.005.

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 26 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 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Concentration (Cmax) (Pharmacokinentic Parameter (PK)) for All Subjects in the Pharmacokinetically Evaluable (ASPE) Group (time frame: 21 days of active treatment and washout period thereafter). The study lists 4 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 NCT01044056, which also lists 1 linked publication.

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 4 Feb 2022.