ContraceptionPhase 3NCT00511433
Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)
A Phase 3 study testing NOMAC-E2 and DRSP-EE in people with Contraception, run by Organon and Co.
Trial summary
The primary purpose of this study is to evaluate the effects of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) on ovarian function. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- NOMAC-E2 and DRSP-EE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Jan 2008
- Phase
- Phase 3
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to use COC for at least 6 cycles.
- 18 - 35 years of age at screening.
- Body Mass Index (BMI) of >/= 17 and </= 35.
- Good physical and mental health.
- Willing to use condoms as the sole contraceptive method during screening cycle and 1 post-treatment cycle.
- Willing to give informed consent.
Who cannot join
- Contraindications for contraceptive steroids (general).
- Additional contraindications (renal, hepatic or adrenal insufficiency).
- Breastfeeding.
- Present use (or use within 2 months prior to 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).
- Administration of any other investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
- Abnormal cervical smear at screening, or documentation of an abnormal smear performed within 6 months before screening.
- Clinically relevant abnormal laboratory result at screening as judged by the investigator.
About this study
Official title: A Randomized, Open-Label, Comparative Trial to Evaluate the Effects on Ovarian Function of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2), Compared to a Monophasic COC Containing 3 mg Drospirenone (DRSP) and 30 ug Ethinyl Estradiol (EE)
The primary purpose of this study is to evaluate the effects of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) on ovarian function.
- Conditions
- Contraception
- Being tested
- NOMAC-E2, DRSP-EE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOMAC-E2Drug
Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28
for 6 consecutive 28-day menstrual cycles.
DRSP-EEDrug
Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day menstrual cycles.
| Study group | Role | What they receive |
|---|---|---|
| NOMAC-E2 | Experimental | Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic combined oral contraceptive Receives: Drug: NOMAC-E2 |
| DRSP-EE | Active comparator | Drospirenone (DRSP) and Ethinyl Estradiol (EE), 3 mg DRSP and 30 mcg EE monophasic combined oral contraceptive Receives: Drug: DRSP-EE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation
During treatment, ovulation was assessed for each participant by the investigator on the basis of ultrasound scanning (USS). The final analysis was based on assessor-blind adjudication.
Measured: Cycle 1, Cycle 2, and Cycle 6
Effect on Ovarian Function as Determined by the Maximum Follicle Diameter
The maximum follicular diameter was defined as the largest follicular diameter during a treatment cycle.
Measured: Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Effect on Ovarian Function as Determined by the Maximum Progesterone Value
The maximum progesterone value was defined as the largest value during a cycle.
Measured: Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2)
The parameter was measured at pre-defined study days.
Measured: Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH)
The parameter was measured at pre-defined study days.
Measured: Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Effect on Ovarian Function as Determined by Luteinizing Hormone (LH)
The parameter was measured at pre-defined study days.
Measured: Cycle 1, Cycle 2, Cycle 3, and Cycle 6
Secondary outcomes (11)
Effect on Cervical Mucus as Determined by Insler Score
The Insler Score was assessed on Day 6 after ovulation during the Screening Cycle, on Day 21 of Cycle 1, and when the maximum follicle diameter was greater than or equal to 15 mm. The Insler Score consisted of four categories each scaled from 0 (none) to 3 (complete). The higher the score, the greater the cervical reaction.
Measured: Screening Cycle, Cycle 1, Cycle 2, and Cycle 7 (post-treatment cycle)
Effect on Maximum Endometrial Thickness
Maximum endometrial thickness was defined as the largest endometrial thickness during a cycle.
Measured: Screening Cycle, Cycle 1, Cycle 2, and Cycle 6
Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 woman years) that the women were under risk of becoming pregnant.
Measured: 6 cycles
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
Measured: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
Measured: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Breakthrough Bleeding
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle.
Measured: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2:21-day period starting on Day 4 of the cycle.
Measured: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current "expected bleeding period". Expected bleeding period: DRSP-EE: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
Measured: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the "expected non-bleeding period" of the next cycle. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
Measured: Every 28-day cycle for 5 cycles
Average Number of Breakthrough Bleeding/Spotting Days
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
Measured: Every 28-day cycle for 6 cycles
Average Number of Withdrawal Bleeding Days
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using diary card booklets. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
Measured: Every 28-day cycle for 6 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startOct 2006
- Primary completionJan 2008
- Study completionJan 2008
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511433
- Sponsor's protocol ID
- P05723
- Other IDs
- Organon protocol 292003
- Status last verified
- Feb 2022
- First submitted
- 2 Aug 2007
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Duijkers IJ, Klipping C, Grob P, Korver T. Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17 beta-oestradiol on ovarian function in comparison to a monophasic combined oral contraceptive containing drospirenone and ethinylestradiol. Eur J Contracept Reprod Health Care. 2010 Oct;15(5):314-25. doi: 10.3109/13625187.2010.504313.
PubMed 20695770
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Comparative Trial to Evaluate the Effects on Ovarian Function of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2), Compared to a Monophasic COC Containing 3 mg Drospirenone (DRSP) and 30 ug Ethinyl Estradiol (EE)
- ClinicalTrials.gov ID
- NCT00511433
- Acronym / sponsor ID
- P05723
- Conditions
- Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 3 Aug 2007 (estimated)
- Results
- Posted 29 Aug 2011
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 study is to evaluate the effects of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) on ovarian function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOMAC-E2 | Experimental | Drug: NOMAC-E2Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic combined oral contraceptive |
| DRSP-EE | Active comparator | Drug: DRSP-EEDrospirenone (DRSP) and Ethinyl Estradiol (EE), 3 mg DRSP and 30 mcg EE monophasic combined oral contraceptive |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Willing to use COC for at least 6 cycles.
- 18 - 35 years of age at screening.
- Body Mass Index (BMI) of >/= 17 and </= 35.
- Good physical and mental health.
- Willing to use condoms as the sole contraceptive method during screening cycle and 1 post-treatment cycle.
Key exclusion criteria (8 listed)
- Contraindications for contraceptive steroids (general).
- Additional contraindications (renal, hepatic or adrenal insufficiency).
- Breastfeeding.
- Present use (or use within 2 months prior to 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).
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 |
|---|---|---|
| NOMAC-E2Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day menstrual cycles. | Drug | NOMAC-E2 |
| DRSP-EEDrospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day menstrual cycles. | Drug | DRSP-EE |
Primary outcome
Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation
Time frame: Cycle 1, Cycle 2, and Cycle 6
During treatment, ovulation was assessed for each participant by the investigator on the basis of ultrasound scanning (USS). The final analysis was based on assessor-blind adjudication.
Effect on Ovarian Function as Determined by the Maximum Follicle Diameter
Time frame: Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6
The maximum follicular diameter was defined as the largest follicular diameter during a treatment cycle.
Effect on Ovarian Function as Determined by the Maximum Progesterone Value
Time frame: Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6
The maximum progesterone value was defined as the largest value during a cycle.
Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2)
Time frame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6
The parameter was measured at pre-defined study days.
Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH)
Time frame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6
The parameter was measured at pre-defined study days.
Effect on Ovarian Function as Determined by Luteinizing Hormone (LH)
Time frame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6
The parameter was measured at pre-defined study days.
11 secondary outcomes
Effect on Cervical Mucus as Determined by Insler Score
Time frame: Screening Cycle, Cycle 1, Cycle 2, and Cycle 7 (post-treatment cycle)
Effect on Maximum Endometrial Thickness
Time frame: Screening Cycle, Cycle 1, Cycle 2, and Cycle 6
Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
Time frame: 6 cycles
Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting
Time frame: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Absence of Withdrawal Bleeding
Time frame: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Breakthrough Bleeding
Time frame: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)
Time frame: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Early Withdrawal Bleeding
Time frame: Every 28-day cycle for 6 cycles
Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Time frame: Every 28-day cycle for 5 cycles
Average Number of Breakthrough Bleeding/Spotting Days
Time frame: Every 28-day cycle for 6 cycles
Average Number of Withdrawal Bleeding Days
Time frame: Every 28-day cycle for 6 cycles
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20695770Duijkers IJ, Klipping C, Grob P, Korver T. Effects of a monophasic combined oral contraceptive containing nomegestrol acetate and 17 beta-oestradiol on ovarian function in comparison to a monophasic combined oral contraceptive containing drospirenone and ethinylestradiol. Eur J Contracept Reprod Health Care. 2010 Oct;15(5):314-25. doi: 10.3109/13625187.2010.504313.
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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 3 study testing NOMAC-E2 and DRSP-EE in people with Contraception, 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 8 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 9 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 29 Aug 2011). 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?
Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation (time frame: Cycle 1, Cycle 2, and Cycle 6). The study lists 6 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 NCT00511433, 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 9 Feb 2022.