Contraceptives, OralPhase 2NCT00673686
Study to Investigate the Effect of Missed Pills on Follicular Development in Two Application Regimens of SH T 00186 D
A Phase 2 study testing YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) and Yasminelle (SH T 00186 D) in people with Contraceptives, Oral, run by Bayer at 1 site in Netherlands.
Trial summary
In this study a comparison was made on the influence of missing pills on follicular ripening. By missing a given number of pills, an effect on "contraceptive robustness" of the two investigated contraceptive pills was measured by ultrasound comparison of follicular size and other parameters which indicate how far… 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
- Contraceptives, Oral
- What is being tested?
- YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) and Yasminelle (SH T 00186 D)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2004to Feb 2005
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women aged 18 to 35 years inclusive (smokers aged up to 30 years inclusive)
- No contraindications for combined oral contraceptive (COC) use
- Follicular diameter of greater-equal than 15 mm on visit 6 (admission to treatment), or an observed ovulation during pretreatment cycle Exclusion Criteria:
- Pregnancy or lactation- Substantial overweight, i.e., body mass index (BMI) > 30,
- Known hypersensitivity to any of the study drug ingredients
- Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study, or the interpretation of the results
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Center, Double-blind, Randomized Study to Compare the Effect of SH T 00186 D on Follicular Development in a 24-day Regimen Versus a 21-day Regimen in Healthy Female Volunteers
In this study a comparison was made on the influence of missing pills on follicular ripening. By missing a given number of pills, an effect on "contraceptive robustness" of the two investigated contraceptive pills was measured by ultrasound comparison of follicular size and other parameters which indicate how far ovulation might be.
- Conditions
- Contraceptives, Oral
- Being tested
- YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300), Yasminelle (SH T 00186 D)
- Keywords
- Oral contraceptive, Ovulation, Missing pills, Intake compliance, Cycle control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)Drug
SH T 00186 D in a 24-day regimen, i.e., 24 verum tablets, 4 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each
Yasminelle (SH T 00186 D)Drug
SH T 00186 D in a 21-day regimen, i.e., 21 verum tablets, 7 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 | Active comparator | Not described Receives: Drug: Yasminelle (SH T 00186 D) |
| Arm 1 | Experimental | Not described Receives: Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hoogland scores in cycles 2 and 3
Measured: Treatment cycles 2 and 3 (treatment weeks 5-12)
Secondary outcomes (4)
Follicle size
Measured: Treatment cycles 2 and 3 (treatment weeks 5-12
Hormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormone
Measured: Treatment cycles 2 and 3 (treatment weeks 5-12
Endometrial thickness
Measured: Treatment cycles 2 and 3 (treatment weeks 5-12
Cervical mucus
Measured: Treatment cycles 2 and 3 (treatment weeks 5-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startMay 2004
- Primary completionFeb 2005
- Study completionFeb 2005
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 Contraceptives, OralStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673686
- Sponsor's protocol ID
- 91377
- Other IDs
- 308382
- Status last verified
- Oct 2014
- First submitted
- 6 May 2008
- Last updated
- 13 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Anttila L, Neunteufel W, Petraglia F, Marr J, Kunz M. Cycle control and bleeding pattern of a 24/4 regimen of drospirenone 3 mg/ethinylestradiol 20 mug compared with a 21/7 regimen of desogestrel 150 mug/ethinylestradiol 20 mug: a pooled analysis. Clin Drug Investig. 2011;31(8):519-525. doi: 10.2165/11590260-000000000-00000.
PubMed 21721590
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Double-blind, Randomized Study to Compare the Effect of SH T 00186 D on Follicular Development in a 24-day Regimen Versus a 21-day Regimen in Healthy Female Volunteers
- ClinicalTrials.gov ID
- NCT00673686
- Acronym / sponsor ID
- 91377
- Conditions
- Contraceptives, Oral
- Keywords
- Oral contraceptive, Ovulation, Missing pills, Intake compliance, Cycle control
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 7 May 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.
In this study a comparison was made on the influence of missing pills on follicular ripening. By missing a given number of pills, an effect on "contraceptive robustness" of the two investigated contraceptive pills was measured by ultrasound comparison of follicular size and other parameters which indicate how far ovulation might be.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 2 | Active comparator | Drug: Yasminelle (SH T 00186 D) |
| Arm 1 | Experimental | Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy women aged 18 to 35 years inclusive (smokers aged up to 30 years inclusive)
- No contraindications for combined oral contraceptive (COC) use
- Follicular diameter of greater-equal than 15 mm on visit 6 (admission to treatment), or an observed ovulation during pretreatment cycle Exclusion Criteria:
- Pregnancy or lactation- Substantial overweight, i.e., body mass index (BMI) > 30,
- Known hypersensitivity to any of the study drug ingredients
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)SH T 00186 D in a 24-day regimen, i.e., 24 verum tablets, 4 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each | Drug | Arm 1 |
| Yasminelle (SH T 00186 D)SH T 00186 D in a 21-day regimen, i.e., 21 verum tablets, 7 placebo tablets Dose: 0.02 mg EE, 3 mg DRSPMode of administration: Oral, 1 tablet dailyDuration of treatment: 3 cycles of 28 days each | Drug | Arm 2 |
Primary outcome
Hoogland scores in cycles 2 and 3
Time frame: Treatment cycles 2 and 3 (treatment weeks 5-12)
4 secondary outcomes
Follicle size
Time frame: Treatment cycles 2 and 3 (treatment weeks 5-12
Hormone levels of progesterone, estradiol, luteinizing hormone, follicle stimulating hormone
Time frame: Treatment cycles 2 and 3 (treatment weeks 5-12
Endometrial thickness
Time frame: Treatment cycles 2 and 3 (treatment weeks 5-12
Cervical mucus
Time frame: Treatment cycles 2 and 3 (treatment weeks 5-12
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 13 Oct 2014.
- Results publication: PubMed 21721590Anttila L, Neunteufel W, Petraglia F, Marr J, Kunz M. Cycle control and bleeding pattern of a 24/4 regimen of drospirenone 3 mg/ethinylestradiol 20 mug compared with a 21/7 regimen of desogestrel 150 mug/ethinylestradiol 20 mug: a pooled analysis. Clin Drug Investig. 2011;31(8):519-525. doi: 10.2165/11590260-000000000-00000.
Related trials for Contraceptives, Oral
RecruitingObservational study
Postprandial Glucose Handing in Contraceptive and IUD Users
Glucose Homeostasis
Active, not recruitingPhase 1
A Study to Investigate the Effect of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity
Healthy Participants
RecruitingPhase 1
A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies
Advanced Malignancies
RecruitingPhase 1
A Study of Eloralintide (LY3841136) in Female Participants With Obesity or Overweight
Obesity, Overweight
RecruitingPhase 1
A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy Participants
Healthy Volunteers
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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) and Yasminelle (SH T 00186 D) in people with Contraceptives, Oral, run by Bayer at 1 site in Netherlands.
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 0 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 13 Oct 2014. 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 Netherlands. 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.
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?
Hoogland scores in cycles 2 and 3 (time frame: Treatment cycles 2 and 3 (treatment weeks 5-12)). 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 NCT00673686, 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 13 Oct 2014.