HealthyPhase 1NCT00711607
A Trial to Assess the Pharmacokinetic Profile (e.g., Uptake, Distribution and Excretion of a Substance in the Body) of Nomegestrol Acetate (NOMAC), Estradiol (E2) and Estrone (E1) After Multiple and Single Dose Administration of the Combined Oral Contraception NOMAC-E2 (COMPLETED)(P05822)
A Phase 1 study testing nomegestrol acetate and estradiol in people with Healthy, run by Organon and Co.
Trial summary
The primary purpose of this trial is to assess the pharmacokinetic profile of NOMAC, E2 and E1 after multiple and single dose administration of the combined oral contraceptive NOMAC-E2 Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- nomegestrol acetate and estradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2007to 1 Sep 2007
- Phase
- Phase 1
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fertile female subjects in good physical and mental health and 18 - 50 years of age at screening
- Body mass index (BMI) of 17 ≤ BMI ≤ 29 kg/m2
- Able and willing to use non-hormonal contraceptives during the trial from screening up to follow up
- With the last menstrual cycle of 28 +/- 7 days
- Able and willing to sign the informed consent form
- Able to refrain from smoking, grapefruit containing products, and all use of (methyl)xanthines (e.g. coffee, tea, cola, chocolate) during hospitalization and during pharmacokinetic sampling on days 24-30 and days 35-41
Who cannot join
- History of sensitivity/idiosyncrasy to NOMAC-E2 or chemically related compounds or excipients which could be employed within the study or to any other unknown drug used in the past
- Use of any drug or substance within one week prior to the first treatment day, except paracetamol
- Clinically relevant history or presence of any medical disorder
- Clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening (and just prior to dosing)
- Known or suspected pregnancy
- History of/or current abuse of drugs or alcohol or solvents, or positive drug or alcohol screen at screening and admission, as judged by the investigator
Show all 18Show fewer
- Positive test result on hepatitis B surface antigen, hepatitis C antibody, or HIV 1/2 serology
- Participation in an investigational drug study within 90 days prior to treatment day 1
- Donation of blood within 90 days prior to treatment day 1
- Contra-indications of contraceptive steroids (general)
- Abnormal cervical smear at screening, or documentation of abnormal smear performed within 12 months before screening
- Clinically relevant transvaginal ultrasound pathology or inability to undergo transvaginal ultrasound evaluation
- Use of an injectable hormonal method of contraception; within 6 months of an injectable with a 3-month duration, within 4 months of an injectable with a 2-month duration, within 2 months of an injectable with a 1-month duration
- Before spontaneous menstruation has occurred following a delivery or abortion
- Breastfeeding or within 2 months after stopping breast feeding prior to start of trial medication
- Present use or use during two months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and post treatment contraceptive method) and herbal remedies containing hypericum perforatum (St. John's Wort)
- Present use or use within one month prior to screening of any agent that was known to prolong the QT/QTc interval
- History of /or current risk factors for TdP (e.g. heart failure, hypokaliemia, hypomagnesaemia, hypocalcaemia, family history of long QT syndrome, loss of consciousness)
About this study
Official title: A Combined Multiple Dose and Single Dose Trial to Assess the Pharmacokinetic Profile of NOMAC, E2 and E1 After Oral Administration of NOMAC-E2 in Healthy Female Volunteers
The primary purpose of this trial is to assess the pharmacokinetic profile of NOMAC, E2 and E1 after multiple and single dose administration of the combined oral contraceptive NOMAC-E2
Read the detailed description
This trial was designed to assess the pharmacokinetic profile of NOMAC, E2 and E1 after multiple dose (MD) and single dose (SD) administration of NOMAC-E2 in healthy female volunteers.
In total 25 subjects were to enter the trial. These subjects were synchronized for menstrual cycle by taking 1 tablet NOMAC-E2 (2.5 mg / 1.5 mg) daily for a minimum of 2 weeks. This was followed by a 7-day pill-free interval. After this, all subjects were to be exposed to the open-label MD treatment with 1 tablet NOMAC-E2 (2.5 mg / 1.5 mg) once daily, during 24 days. This was followed by a second pill-free interval of 10 days, to allow for sufficient washout of NOMAC-E2. On treatment day 35, 20 subjects were to receive 1 tablet NOMAC-E2 (2.5 mg / 1.5 mg) and 5 subjects were to receive a placebo tablet in a double blinded setup. After treatment day 35 and before follow-up, all subjects would again have a pill-free interval of 7 days. After follow-up, all subjects could return to their own contraceptive schedule. Follow-up took place on treatment day 42.
Bleeding pattern and tablet intake were assessed by means of a subject diary to be completed on a daily basis. Blood sampling for pharmacokinetic and pharmacodynamic purposes were collected at several time points before, during and after the MD and SD period. In order to explore any possible influence of NOMAC-E2 on the QT/QTc interval, a small placebo group was designed within the SD period, to allow for comparison with the active-treated group. In addition several safety assessments (vital signs, ECGs, trans vaginal ultrasound evaluation, physical, gynecological and breast examinations, cervical smear, routine laboratory parameters and adverse events) were performed.
- Conditions
- Healthy
- Being tested
- nomegestrol acetate and estradiol
- Keywords
- pharmacokinetics (PK), combined oral contraceptive, nomegestrol acetate, estradiol, NOMAC, E2, NOMAC-E2, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nomegestrol acetate and estradiolDrug
Also called NOMAC-E2; Org 10486-0 + Org 2317
Group 1: one tablet of 2.5 mg NOMAC-E2 and 1.5 mg E2 per day on days 1-24 and day 35; Group 2: one tablet of 2.5 mg NOMAC-E2 and 1.5 mg E2 per day on days 1-24 followed by one Placebo tablet on day 35
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Group 1: NOMAC-E2 (days 1-24 and day 35) Receives: Drug: nomegestrol acetate and estradiol |
| 2 | Placebo comparator | Group 2: NOMAC-E2 (days 1-24) followed by Placebo (day 35) Receives: Drug: nomegestrol acetate and estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of NOMAC and serum concentrations of E2 and E1 measured at several time points before, during and after multiple dose and after single dose administration to determine pharmacokinetics
Measured: days 1 to 24, and days 34 - 42
Secondary outcomes (3)
Time-matched mean effects of QTcB, QTcF and QTcI values (respectively Bazett, Fredericia and Individual correction methods) compared to placebo, and time-matched changes from baseline
Measured: Screening (week -5), days 34, 35 and 42;
Drug safety as determined by gynecological and breast examination, trans vaginal ultrasound evaluation, pregnancy test, vital signs, ECG recordings, adverse events monitoring, routine laboratory parameters
Measured: From week -5 (screening) upto and including day 42 (followup)
Pharmacodynamics as determined by measuring serum concentrations of progesterone, luteinizing hormone (LH), follicle stimulating hormone (FSH) and sex hormone binding globulin (SHBG)
Measured: days 1 to 24, and days 34 - 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study start1 May 2007
- Primary completion1 Sep 2007
- Study completion1 Sep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CRS Mannheim GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711607
- Sponsor's protocol ID
- P05822
- Other IDs
- 292006
- Status last verified
- Feb 2022
- First submitted
- 3 Jul 2008
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Gerrits MG, Schnabel PG, Post TM, Peeters PA. Pharmacokinetic profile of nomegestrol acetate and 17beta-estradiol after multiple and single dosing in healthy women. Contraception. 2013 Feb;87(2):193-200. doi: 10.1016/j.contraception.2012.07.001. Epub 2012 Aug 13.
PubMed 22898360
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Multiple Dose and Single Dose Trial to Assess the Pharmacokinetic Profile of NOMAC, E2 and E1 After Oral Administration of NOMAC-E2 in Healthy Female Volunteers
- ClinicalTrials.gov ID
- NCT00711607
- Acronym / sponsor ID
- P05822
- Conditions
- Healthy
- Keywords
- pharmacokinetics (PK), combined oral contraceptive, nomegestrol acetate, estradiol, NOMAC, E2, NOMAC-E2, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- CRS Mannheim GmbH
- Study start
- 1 May 2007 (actual)
- Primary completion
- 1 Sep 2007 (actual)
- Study completion
- 1 Sep 2007 (actual)
- First posted
- 9 Jul 2008 (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 primary purpose of this trial is to assess the pharmacokinetic profile of NOMAC, E2 and E1 after multiple and single dose administration of the combined oral contraceptive NOMAC-E2
Detailed description
This trial was designed to assess the pharmacokinetic profile of NOMAC, E2 and E1 after multiple dose (MD) and single dose (SD) administration of NOMAC-E2 in healthy female volunteers.
In total 25 subjects were to enter the trial. These subjects were synchronized for menstrual cycle by taking 1 tablet NOMAC-E2 (2.5 mg / 1.5 mg) daily for a minimum of 2 weeks. This was followed by a 7-day pill-free interval. After this, all subjects were to be exposed to the open-label MD treatment with 1 tablet NOMAC-E2 (2.5 mg / 1.5 mg) once daily, during 24 days. This was followed by a second pill-free interval of 10 days, to allow for sufficient washout of NOMAC-E2. On treatment day 35, 20 subjects were to receive 1 tablet NOMAC-E2 (2.5 mg / 1.5 mg) and 5 subjects were to receive a placebo tablet in a double blinded setup. After treatment day 35 and before follow-up, all subjects would again have a pill-free interval of 7 days. After follow-up, all subjects could return to their own contraceptive schedule. Follow-up took place on treatment day 42.
Bleeding pattern and tablet intake were assessed by means of a subject diary to be completed on a daily basis. Blood sampling for pharmacokinetic and pharmacodynamic purposes were collected at several time points before, during and after the MD and SD period. In order to explore any possible influence of NOMAC-E2 on the QT/QTc interval, a small placebo group was designed within the SD period, to allow for comparison with the active-treated group. In addition several safety assessments (vital signs, ECGs, trans vaginal ultrasound evaluation, physical, gynecological and breast examinations, cervical smear, routine laboratory parameters and adverse events) were performed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: nomegestrol acetate and estradiolGroup 1: NOMAC-E2 (days 1-24 and day 35) |
| 2 | Placebo comparator | Drug: nomegestrol acetate and estradiolGroup 2: NOMAC-E2 (days 1-24) followed by Placebo (day 35) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Fertile female subjects in good physical and mental health and 18 - 50 years of age at screening
- Body mass index (BMI) of 17 ≤ BMI ≤ 29 kg/m2
- Able and willing to use non-hormonal contraceptives during the trial from screening up to follow up
- With the last menstrual cycle of 28 +/- 7 days
- Able and willing to sign the informed consent form
Key exclusion criteria (18 listed)
- History of sensitivity/idiosyncrasy to NOMAC-E2 or chemically related compounds or excipients which could be employed within the study or to any other unknown drug used in the past
- Use of any drug or substance within one week prior to the first treatment day, except paracetamol
- Clinically relevant history or presence of any medical disorder
- Clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening (and just prior to dosing)
- Known or suspected pregnancy
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 |
|---|---|---|
| nomegestrol acetate and estradiolAlso: NOMAC-E2; Org 10486-0 + Org 2317Group 1: one tablet of 2.5 mg NOMAC-E2 and 1.5 mg E2 per day on days 1-24 and day 35; Group 2: one tablet of 2.5 mg NOMAC-E2 and 1.5 mg E2 per day on days 1-24 followed by one Placebo tablet on day 35 | Drug | 1, 2 |
Primary outcome
Plasma concentrations of NOMAC and serum concentrations of E2 and E1 measured at several time points before, during and after multiple dose and after single dose administration to determine pharmacokinetics
Time frame: days 1 to 24, and days 34 - 42
3 secondary outcomes
Time-matched mean effects of QTcB, QTcF and QTcI values (respectively Bazett, Fredericia and Individual correction methods) compared to placebo, and time-matched changes from baseline
Time frame: Screening (week -5), days 34, 35 and 42;
Drug safety as determined by gynecological and breast examination, trans vaginal ultrasound evaluation, pregnancy test, vital signs, ECG recordings, adverse events monitoring, routine laboratory parameters
Time frame: From week -5 (screening) upto and including day 42 (followup)
Pharmacodynamics as determined by measuring serum concentrations of progesterone, luteinizing hormone (LH), follicle stimulating hormone (FSH) and sex hormone binding globulin (SHBG)
Time frame: days 1 to 24, and days 34 - 42
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 3 Feb 2022.
- Results publication: PubMed 22898360Gerrits MG, Schnabel PG, Post TM, Peeters PA. Pharmacokinetic profile of nomegestrol acetate and 17beta-estradiol after multiple and single dosing in healthy women. Contraception. 2013 Feb;87(2):193-200. doi: 10.1016/j.contraception.2012.07.001. Epub 2012 Aug 13.
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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?
A Phase 1 study testing nomegestrol acetate and estradiol in people with Healthy, run by Organon and Co.
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 6 inclusion and 18 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 3 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Plasma concentrations of NOMAC and serum concentrations of E2 and E1 measured at several time points before, during and after multiple dose and after single dose administration to determine pharmacokinetics (time frame: days 1 to 24, and days 34 - 42). 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 NCT00711607, 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 3 Feb 2022.