Clinical trial NCT01291004: A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral Contraceptives
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Follicle Development
Ovarian Follicle
Follicle Count
Follicle Size
Oral Contraceptive
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-07
Enrollment: 206
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16.
timeFrame: 16 weeks
measure: Change in serum Estradiol level from baseline to week 16.
timeFrame: 16 weeks
measure: Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16.
timeFrame: 16 weeks
measure: Change in serum Progesterone level from baseline to week 20.
timeFrame: 20 weeks
Secondary outcomes:
measure: Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels.
timeFrame: 15 weeks
measure: Change from baseline to week 15 in D-dimer.
timeFrame: 15 weeks
measure: Change from baseline to end of week 15 in Plasmin-Antiplasmin complex
timeFrame: 15 weeks
measure: Change from baseline to week 15 in APTT and ETP based activated protein-C resistance (APC).
timeFrame: 15 weeks
measure: Change from baseline to week 15 in Fibrinogen.
timeFrame: 15 weeks
measure: Change from baseline to week 15 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S.
timeFrame: 15 weeks
measure: Change from baseline to week 15 in Tissue Plasminogen Activator (t-PA).
timeFrame: 15 weeks
measure: Change from baseline to week 15 in Antithrombin.
timeFrame: 15 weeks
measure: Change from baseline to week 15 in Tissue Factor Pathway Inhibitor (TFPI).
timeFrame: 15 weeks
measure: Change from baseline to week 15 in Total Cortisol and Corticosteroid Binding Globulin (CBG).
timeFrame: 15 weeks
measure: Change from baseline to week 15 in Thyroid Stimulating Hormone (TSH).
timeFrame: 15 weeks
measure: Change from baseline to week 15 in Sex Hormone Binding Globulin (SHBG).
timeFrame: 15 weeks
measure: Return to ovulation rate at week 20.
timeFrame: Week 20
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Teva Investigational Site 10119
state: Pennsylvania
city: Seattle
country: United States
facility: Teva Investigational Site 10118
state: Washington
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Women's Health Research Protocol Chair
role: STUDY_CHAIR
References: