Follicle DevelopmentPhase 1NCT01291004
A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives
A Phase 1 study testing Desogestrel/ethinyl estradiol and ethinyl estradiol, 28-day drospirenone oral contraceptive and 28-day levonorgestrel oral contraceptive in people with Follicle Development and Ovarian Follicle, run by Teva Branded Pharmaceutical Products R&D, Inc. at 2 sites in United States.
Trial summary
This study is being conducted to evaluate the impact of a 28-day oral contraceptive compared to two 28-day oral contraceptive regimens containing different synthetic progestins on ovarian follicular activity and hormone levels in healthy women. 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
- Follicle Development, Ovarian Follicle, Follicle Count
- What is being tested?
- Desogestrel/ethinyl estradiol and ethinyl estradiol, 28-day drospirenone oral contraceptive and 28-day levonorgestrel oral contraceptive
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2011to 31 Mar 2012
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenopausal, non-pregnant, non-lactating women age 18-35 years old
- Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m²
- Regular spontaneous menstrual cycle
- Others as dictated by Food and Drug Administration (FDA)-approved protocol
Who cannot join
- Any condition which contraindicates the use of combination oral contraceptives
- Known thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenic valvulopathies or rhythm disorders
- Migraine headaches with focal, neurological symptoms
- Others as dictated by FDA-approved protocol
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Teva Investigational Site 10119
Philadelphia, Pennsylvania, 19114
Teva Investigational Site 10118
Seattle, Washington, 98105
About this study
Official title: A Multicenter, Open-Label Study to Evaluate Ovarian Follicular Activity and Hormone Levels With the Oral Contraceptive Regimen DR-102 Compared to Two 28-day Oral Contraceptive Regimens Containing Different Synthetic Progestins
This study is being conducted to evaluate the impact of a 28-day oral contraceptive compared to two 28-day oral contraceptive regimens containing different synthetic progestins on ovarian follicular activity and hormone levels in healthy women.
- Being tested
- Desogestrel/ethinyl estradiol and ethinyl estradiol, 28-day drospirenone oral contraceptive, 28-day levonorgestrel oral contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desogestrel/ethinyl estradiol and ethinyl estradiolDrug
Desogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet
28-day drospirenone oral contraceptiveDrug
Drospirenone/ethinyl estradiol 0.3/0.02 mg
28-day levonorgestrel oral contraceptiveDrug
Levonorgestrel/ethinyl estradiol 0.1/0.02 mg
| Study group | Role | What they receive |
|---|---|---|
| 28-day Desogestrel Oral Contraceptive | Experimental | Not described Receives: Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol |
| 28-day Drospirenone Oral Contraceptive | Active comparator | Not described Receives: Drug: 28-day drospirenone oral contraceptive |
| 28-day Levonorgestrel Oral Contraceptive | Active comparator | Not described Receives: Drug: 28-day levonorgestrel oral contraceptive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16.
Measured: 16 weeks
Change in serum Estradiol level from baseline to week 16.
Measured: 16 weeks
Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16.
Measured: 16 weeks
Change in serum Progesterone level from baseline to week 20.
Measured: 20 weeks
Secondary outcomes (13)
Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels.
Measured: 15 weeks
Change from baseline to week 15 in D-dimer.
Measured: 15 weeks
Change from baseline to end of week 15 in Plasmin-Antiplasmin complex
Measured: 15 weeks
Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC).
Measured: 15 weeks
Change from baseline to week 15 in Fibrinogen.
Measured: 15 weeks
Change from baseline to week 15 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S.
Measured: 15 weeks
Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA).
Measured: 15 weeks
Change from baseline to week 15 in Antithrombin.
Measured: 15 weeks
Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI).
Measured: 15 weeks
Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG).
Measured: 15 weeks
Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH).
Measured: 15 weeks
Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG).
Measured: 15 weeks
Return to ovulation rate at week 20.
Measured: Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study start31 Jan 2011
- Primary completion31 Mar 2012
- Study completion31 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicle DevelopmentStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Women's Health Research Protocol Chair, Study chair, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291004
- Sponsor's protocol ID
- DSG-OI-101
- Status last verified
- Dec 2021
- First submitted
- 4 Feb 2011
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Study to Evaluate Ovarian Follicular Activity and Hormone Levels With the Oral Contraceptive Regimen DR-102 Compared to Two 28-day Oral Contraceptive Regimens Containing Different Synthetic Progestins
- ClinicalTrials.gov ID
- NCT01291004
- Acronym / sponsor ID
- DSG-OI-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2011 (actual)
- Primary completion
- 31 Mar 2012 (actual)
- Study completion
- 31 Mar 2012 (actual)
- First posted
- 7 Feb 2011 (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.
This study is being conducted to evaluate the impact of a 28-day oral contraceptive compared to two 28-day oral contraceptive regimens containing different synthetic progestins on ovarian follicular activity and hormone levels in healthy women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 28-day Desogestrel Oral Contraceptive | Experimental | Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol |
| 28-day Drospirenone Oral Contraceptive | Active comparator | Drug: 28-day drospirenone oral contraceptive |
| 28-day Levonorgestrel Oral Contraceptive | Active comparator | Drug: 28-day levonorgestrel oral contraceptive |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Premenopausal, non-pregnant, non-lactating women age 18-35 years old
- Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m²
- Regular spontaneous menstrual cycle
- Others as dictated by Food and Drug Administration (FDA)-approved protocol
Key exclusion criteria (4 listed)
- Any condition which contraindicates the use of combination oral contraceptives
- Known thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenic valvulopathies or rhythm disorders
- Migraine headaches with focal, neurological symptoms
- Others as dictated by FDA-approved protocol
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 |
|---|---|---|
| Desogestrel/ethinyl estradiol and ethinyl estradiolDesogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet | Drug | 28-day Desogestrel Oral Contraceptive |
| 28-day drospirenone oral contraceptiveDrospirenone/ethinyl estradiol 0.3/0.02 mg | Drug | 28-day Drospirenone Oral Contraceptive |
| 28-day levonorgestrel oral contraceptiveLevonorgestrel/ethinyl estradiol 0.1/0.02 mg | Drug | 28-day Levonorgestrel Oral Contraceptive |
Primary outcome
Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16.
Time frame: 16 weeks
Change in serum Estradiol level from baseline to week 16.
Time frame: 16 weeks
Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16.
Time frame: 16 weeks
Change in serum Progesterone level from baseline to week 20.
Time frame: 20 weeks
13 secondary outcomes
Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels.
Time frame: 15 weeks
Change from baseline to week 15 in D-dimer.
Time frame: 15 weeks
Change from baseline to end of week 15 in Plasmin-Antiplasmin complex
Time frame: 15 weeks
Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC).
Time frame: 15 weeks
Change from baseline to week 15 in Fibrinogen.
Time frame: 15 weeks
Change from baseline to week 15 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S.
Time frame: 15 weeks
Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA).
Time frame: 15 weeks
Change from baseline to week 15 in Antithrombin.
Time frame: 15 weeks
Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI).
Time frame: 15 weeks
Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG).
Time frame: 15 weeks
Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH).
Time frame: 15 weeks
Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG).
Time frame: 15 weeks
Return to ovulation rate at week 20.
Time frame: Week 20
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 8 Dec 2021.
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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.
Teva Women's Health Research Protocol Chair study chair
Teva Branded Pharmaceutical Products R&D, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Desogestrel/ethinyl estradiol and ethinyl estradiol, 28-day drospirenone oral contraceptive and 28-day levonorgestrel oral contraceptive in people with Follicle Development and Ovarian Follicle, run by Teva Branded Pharmaceutical Products R&D, Inc. at 2 sites in United States.
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 4 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 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 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?
Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16. (time frame: 16 weeks). 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?
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 8 Dec 2021.