OvulationPhase 2NCT00254189
Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation
A Phase 2 study testing Levonorgestrel and Ethinyl Estradiol in people with Ovulation, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
To determine the ability of a monophasic oral contraceptives ("OC") regimen of Levonorgestrel ("LNG") 90 mg and Ethinyl Estradiol ("EE") 20 mg to inhibit ovulation during 84 days of continuous therapy. Read more about this study
- Who is it for?
- Ages 0 to 36 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovulation
- What is being tested?
- Levonorgestrel and Ethinyl Estradiol
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Oct 2004
- Phase
- Phase 2
- 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 0 to 36 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy women of legal age of consent who are willing to use a combination OC.
- Subjects must be under the age of 36 at the time of enrollment (visit 3).
- Subjects must have had regular (24 to 32 day) menstrual cycles for the 3-month period preceding entry into the pretreatment observation cycle, excluding postabortal and nonnursing postpartum subjects. Postabortal and nonnursing postpartum subjects must have completed at least 1 regular (24 to 32 day) spontaneous menstrual cycle before entry into the pretreatment observation cycle. The pretreatment observation cycle for all subjects will begin on day 1 of the subsequent spontaneous menses.
- Other inclusions apply.
Who cannot join
- A history or the presence of any of the following will prevent enrollment:
- Thrombophlebitis, thrombosis, or thromboembolic disorders.
- Deep vein thrombosis.
- Pulmonary embolism.
- Other exclusions apply.
About this study
Official title: A Single Center, Open-Label Study to Evaluate the Effects on Ovulation of Levonorgestrel 90mg and Ethinyl Estradiol 20mg in a Daily, Continuous, Oral Regimen.
To determine the ability of a monophasic oral contraceptives ("OC") regimen of Levonorgestrel ("LNG") 90 mg and Ethinyl Estradiol ("EE") 20 mg to inhibit ovulation during 84 days of continuous therapy.
- Conditions
- Ovulation
- Being tested
- Levonorgestrel, Ethinyl Estradiol
- Keywords
- Ovulation, Oral Contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevonorgestrelDrug
Ethinyl EstradiolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the ability of a monophasic oral contraceptive (OC) regimen of Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg to inhibit ovulation during 84 days of continuous therapy.
Secondary outcomes (1)
To assess the safety profile. To assess the ovarian activity, as measured by the Hoogland and Skouby 6-point grading system, during 84 days of continuous therapy. To evaluate the time to return of ovulation after cessation of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startDec 2002
- Study completionOct 2004
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 OvulationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254189
- Sponsor's protocol ID
- 0858A2-208
- Status last verified
- May 2006
- First submitted
- 11 Nov 2005
- Last updated
- 19 May 2006
- Results posted
- No
Publications
Archer DF, Kovalevsky G, Ballagh SA, Grubb GS. Ovarian activity and safety of a novel levonorgestrel/ethinyl estradiol continuous oral contraceptive regimen. Contraception. 2009 Sep;80(3):245-53. doi: 10.1016/j.contraception.2009.03.006. Epub 2009 May 2.
PubMed 19698816
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-Label Study to Evaluate the Effects on Ovulation of Levonorgestrel 90mg and Ethinyl Estradiol 20mg in a Daily, Continuous, Oral Regimen.
- ClinicalTrials.gov ID
- NCT00254189
- Acronym / sponsor ID
- 0858A2-208
- Conditions
- Ovulation
- Keywords
- Ovulation, Oral Contraceptive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Study completion
- Oct 2004
- First posted
- 15 Nov 2005 (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.
To determine the ability of a monophasic oral contraceptives ("OC") regimen of Levonorgestrel ("LNG") 90 mg and Ethinyl Estradiol ("EE") 20 mg to inhibit ovulation during 84 days of continuous therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 to 36 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Healthy women of legal age of consent who are willing to use a combination OC.
- Subjects must be under the age of 36 at the time of enrollment (visit 3).
- Subjects must have had regular (24 to 32 day) menstrual cycles for the 3-month period preceding entry into the pretreatment observation cycle, excluding postabortal and nonnursing postpartum subjects. Postabortal and nonnursing postpartum subjects must have completed at least 1 regular (24 to 32 day) spontaneous menstrual cycle before entry into the pretreatment observation cycle. The pretreatment observation cycle for all subjects will begin on day 1 of the subsequent spontaneous menses.
- Other inclusions apply.
Key exclusion criteria (5 listed)
- Thrombophlebitis, thrombosis, or thromboembolic disorders.
- Deep vein thrombosis.
- Pulmonary embolism.
- Other exclusions apply.
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 | Drug | – |
| Ethinyl Estradiol | Drug | – |
Primary outcome
To determine the ability of a monophasic oral contraceptive (OC) regimen of Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg to inhibit ovulation during 84 days of continuous therapy.
1 secondary outcome
To assess the safety profile. To assess the ovarian activity, as measured by the Hoogland and Skouby 6-point grading system, during 84 days of continuous therapy. To evaluate the time to return of ovulation after cessation of treatment.
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 19 May 2006.
- Derived from this study: PubMed 19698816Archer DF, Kovalevsky G, Ballagh SA, Grubb GS. Ovarian activity and safety of a novel levonorgestrel/ethinyl estradiol continuous oral contraceptive regimen. Contraception. 2009 Sep;80(3):245-53. doi: 10.1016/j.contraception.2009.03.006. Epub 2009 May 2.
Related trials for Ovulation
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Recruiting
LE + CC vs. LE for Ovulation Induction
Letrozole, Clomiphene Citrate
Recruiting
Dual Trigger VS HCG Trigger for Final Oocyte Maturation in Normal Responders
ICSI, IVF
Not yet recruiting
Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized Controlled Non-Inferiority Trial With a Concurrent Comparator Cohort Undergoing Progestin-Primed Ovarian Stimulation (PPOS)
Infertility, Female, Ovulation Induction
RecruitingPhase 1
E.N.D.E.A.V.O.R.: An Exemestane Needed Dose Efficacy and Verification as an Ovulation Induction Regimen Study
Poly Cystic Ovary Syndrome
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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levonorgestrel and Ethinyl Estradiol in people with Ovulation, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 5 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 19 May 2006. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To determine the ability of a monophasic oral contraceptive (OC) regimen of Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg to inhibit ovulation during 84 days of continuous therapy.. 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 NCT00254189, 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 19 May 2006.