ContraceptionPhase 1/2NCT02957630
"E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"
A Phase 1/2 study testing 15 mg E4/3 mg DRSP, 30 mcg EE/150 mcg LNG and 20 mcg EE/3 mg DRSP in people with Contraception and Liver Metabolism, run by Estetra at 1 site in Netherlands.
Trial summary
The proposed study will provide an assessment of the effect of this combination on endocrine function, metabolic control and hemostasis during 6 treatment cycles. This will be compared to the effects of two reference COCs. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Liver Metabolism, Hemostasis Parameter
- What is being tested?
- 15 mg E4/3 mg DRSP, 30 mcg EE/150 mcg LNG and 20 mcg EE/3 mg DRSP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2016to 9 Oct 2017
- Phase
- Phase 1/2
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult woman
- Negative pregnancy test at subject screening and randomization
- Aged 18-50 years (inclusive) at the time of signing the ICF
- Good physical and mental health on the basis of medical, surgical and gynecological history, physical examination, gynecological examination, clinical laboratory, ECG, echocardiography and vital signs
- BMI from 18.0 to 30.0 kg/m², inclusive, at time of screening visit
- Able to fulfil the requirements of the protocol and have indicated a willingness to participate in the study by providing written informed consent
Who cannot join
- Known hypersensitivity to any of the investigational product ingredients
- Smoking if > 35 years old
- Dyslipoproteinemia or use of antilipidemic agent
- Known diabetes mellitus
- Current use of antidiabetic drugs, including insulin
- Arterial hypertension
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- Any condition associated with an increased risk of venous thromboembolism and/or arterial thromboembolism.
- Any condition associated with abnormal uterine/vaginal bleeding.
- Presence of an undiagnosed breast mass
- Current symptomatic gallbladder disease
- History of pregnancy- or COC-related cholestasis
- Presence or history of severe hepatic disease
- Presence or history of pancreatitis if associated with hypertriglyceridemia
- Porphyria
- Presence or history of benign liver tumors (focal nodular hyperplasia and hepatocellular adenoma)
- Presence of renal impairment (glomerular filtration rate [GFR] <60 mL/min/1.73m²)
- Hyperkalemia or presence of conditions that predispose to hyperkalemia
- Presence or history of hormone-related malignancy
- History of non-hormone-related malignancy within 5 years before screening; subjects with a non-melanoma skin cancer are allowed in the study
- Use of drugs potentially triggering interactions with COCs
- History of alcohol or drug abuse within 12 months prior to screening
- Presence or history of thyroid disorders
- Participation in another investigational drug clinical study within 1 month (30 days) or have received an investigational drug within the last 3 months (90 days) prior to randomization. Subjects who participated in an oral contraceptive clinical study using Food and Drug Administration (FDA)/European Union (EU) approved active ingredients, may be randomized 2 months (60 days) after completing the preceding study
- Sponsor, contract research organization (CRO) or Principal Investigator's (PI's) site personnel directly affiliated with this study
- Is judged by the PI to be unsuitable for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized,Open-label,Controlled, Three-arm Study to Evaluate the Effect of a New Combined Oral Contraceptive (COC) Containing 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP) and of Two Reference COCs Containing Either 30 mcg Ethinylestradiol (EE) and 150 mcg Levonorgestrel (LNG) or 20 mcg EE and 3 mg DRSP on Endocrine Function, Metabolic Control and Hemostasis During 6 Treatment Cycles
The proposed study will provide an assessment of the effect of this combination on endocrine function, metabolic control and hemostasis during 6 treatment cycles. This will be compared to the effects of two reference COCs.
- Conditions
- Contraception, Liver Metabolism, Hemostasis Parameter
- Being tested
- 15 mg E4/3 mg DRSP, 30 mcg EE/150 mcg LNG, 20 mcg EE/3 mg DRSP
- Keywords
- Estetrol (E4), Drospirenone (DRSP), Ethinylestradiol (EE), Levonorgestrel (LNG), Oral contraceptive, Prevention of pregnancy, Hemostasis, Metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 mg E4/3 mg DRSPDrug
Also called 15 mg estetrol and 3 mg drospirenone
15 mg E4 combined with 3 mg DRSP administered in a 24/4-day regimen (i.e. 24 days of pink active tablets followed by 4 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.
30 mcg EE/150 mcg LNGDrug
Also called 30 mcg ethinylestradiol and 150 mcg levonorgestrel
30 mcg EE combined with 150 mcg LNG administered in a 21/7-day regimen (i.e. 21 days of yellow active tablets followed by 7 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.
20 mcg EE/3 mg DRSPDrug
Also called 20 mcg ethinylestradiol and 3 mg drospirenone
20 mcg EE combined with 3 mg DRSP administered in a 24/4-day regimen (i.e. 24 days of pink active tablets followed by 4 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.
| Study group | Role | What they receive |
|---|---|---|
| 15 mg E4/3 mg DRSP | Experimental | 15 mg estetrol/3 mg drospirenone combined oral contraceptive Receives: Drug: 15 mg E4/3 mg DRSP |
| 30 mcg EE/150 mcg LNG | Active comparator | 30 mcg ethinylestradiol/150 mcg levonorgestrel combined oral contraceptive Receives: Drug: 30 mcg EE/150 mcg LNG |
| 20 mcg EE/3 mg DRSP | Active comparator | 20 mcg ethinylestradiol/3 mg drospirenone combined oral contraceptive Receives: Drug: 20 mcg EE/3 mg DRSP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of prothrombin fragment 1+2
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of APC resistance (ETP-based, APTT-based)
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of D-dimer
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of factor VII
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of factor VIII
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of von Willebrand factor
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of factor II
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of antithrombin
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of free and total Protein S
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of protein C
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of plasminogen activator inhibitor type-1 (PAI-1)
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of tissue type plasminogen activator (t-PA)
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of plasminogen
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of free tissue factor pathway inhibitor (TPFI)
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of E-selectin
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of fibrinogen
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of insulin
Measured: At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of glucose
Measured: At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of C-peptide
Measured: At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of glycated hemoglobin (HbA1c)
Measured: At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Homeostasis Model Assessment - Insulin Resistance (HOMA-IR)
Measured: At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Oral glucose tolerance test (OGTT)
Measured: At 0 (pre-glucose challenge), 30, 60, 90, 120 and 180 minutes after glucose challenge during pretreatment Cycle; at 0 (pre-glucose challenge), 30, 60, 90, 120 and 180 minutes after glucose challenge during Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of prolactin
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of follicle-stimulating hormone (FSH)
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of luteinizing hormone (LH)
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of estradiol (E2)
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of progesterone (P)
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of thyroïd stimulating hormone (TSH)
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of free thyroxine (fT3)/free triiodothyronine (fT4)
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of dihydroepiandrostenedione (DHEAS)
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of androstenedione
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of total testosterone (T)
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of dihydrotestosterone (DHT)
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of total cortisol
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of aldosterone
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of high density lipoprotein (HDL)-cholesterol
Measured: At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of low density lipoprotein (LDL)-cholesterol
Measured: At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of total cholesterol
Measured: At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of triglycerides
Measured: At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of lipoprotein (a)
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of apoliporotein A1
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of apoliporotein B
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of C-reactive protein
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of corticosteroid binding globulin (CBG)
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of sex hormone binding globulin (SHBG)
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of thyroxin binding globulin (TBG)
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of angiotensinogen
Measured: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Secondary outcomes (6)
Number of subjects with adverse events as a measure of safety and tolerability
Measured: From up to 28 days before randomization to maximum Day 4 of the Cycle 7 (1 cycle = 28 days).
Serum concentration of lactate dehydrogenase (LDH) 1 and 2
Measured: Between Days 18 and 21 for the pretreatment Cycle and between Days 18 and 21 for the Cycle 6 (1 cycle = 28 days)
Serum concentration of tropinin T and I
Measured: Between Days 18 and 21 for the pretreatment Cycle and between Days 18 and 21 for the Cycle 6 (1 cycle = 28 days)
Electrocardiogram (ECG) parameters
The following ECG parameters will be recorded: heart rate, PR-interval, QRS-duration, QT-interval, QTc interval (Fridericias's)
Measured: At screening and between Days 18 and 21 for Cycle 6 (1 cycle = 28 days).
Echocardiographic parameters
Measured: At screening and between Days 18 and 21 for Cycle 6 (1 cycle = 28 days).
Change from baseline to end of treatment in the different items of the menstrual distress questionnaires (MDQ) form C
Measured: At pretreatment Cycle and between Days 18 and 21 for Cycle 6 (1 cycle = 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startSep 2016
- Primary completion9 Oct 2017
- Study completion9 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Estetra
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Klipping, Principal investigator, Dinox BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957630
- Sponsor's protocol ID
- MIT-Es0001-C201
- Other IDs
- 2016-001316-37, 2016
- Status last verified
- Mar 2017
- First submitted
- 25 Oct 2016
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized,Open-label,Controlled, Three-arm Study to Evaluate the Effect of a New Combined Oral Contraceptive (COC) Containing 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP) and of Two Reference COCs Containing Either 30 mcg Ethinylestradiol (EE) and 150 mcg Levonorgestrel (LNG) or 20 mcg EE and 3 mg DRSP on Endocrine Function, Metabolic Control and Hemostasis During 6 Treatment Cycles
- ClinicalTrials.gov ID
- NCT02957630
- Acronym / sponsor ID
- MIT-Es0001-C201
- Conditions
- Contraception, Liver Metabolism, Hemostasis Parameter
- Keywords
- Estetrol (E4), Drospirenone (DRSP), Ethinylestradiol (EE), Levonorgestrel (LNG), Oral contraceptive, Prevention of pregnancy, Hemostasis, Metabolism
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- EstetraIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- 9 Oct 2017 (actual)
- Study completion
- 9 Oct 2017 (actual)
- First posted
- 8 Nov 2016 (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.
The proposed study will provide an assessment of the effect of this combination on endocrine function, metabolic control and hemostasis during 6 treatment cycles. This will be compared to the effects of two reference COCs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 15 mg E4/3 mg DRSP | Experimental | Drug: 15 mg E4/3 mg DRSP15 mg estetrol/3 mg drospirenone combined oral contraceptive |
| 30 mcg EE/150 mcg LNG | Active comparator | Drug: 30 mcg EE/150 mcg LNG30 mcg ethinylestradiol/150 mcg levonorgestrel combined oral contraceptive |
| 20 mcg EE/3 mg DRSP | Active comparator | Drug: 20 mcg EE/3 mg DRSP20 mcg ethinylestradiol/3 mg drospirenone combined oral contraceptive |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adult woman
- Negative pregnancy test at subject screening and randomization
- Aged 18-50 years (inclusive) at the time of signing the ICF
- Good physical and mental health on the basis of medical, surgical and gynecological history, physical examination, gynecological examination, clinical laboratory, ECG, echocardiography and vital signs
- BMI from 18.0 to 30.0 kg/m², inclusive, at time of screening visit
Key exclusion criteria (25 listed)
- Known hypersensitivity to any of the investigational product ingredients
- Smoking if > 35 years old
- Dyslipoproteinemia or use of antilipidemic agent
- Known diabetes mellitus
- Current use of antidiabetic drugs, including insulin
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 |
|---|---|---|
| 15 mg E4/3 mg DRSPAlso: 15 mg estetrol and 3 mg drospirenone15 mg E4 combined with 3 mg DRSP administered in a 24/4-day regimen (i.e. 24 days of pink active tablets followed by 4 days of white placebo tablets). One tablet per day orally for 6 treatment cycles. | Drug | 15 mg E4/3 mg DRSP |
| 30 mcg EE/150 mcg LNGAlso: 30 mcg ethinylestradiol and 150 mcg levonorgestrel30 mcg EE combined with 150 mcg LNG administered in a 21/7-day regimen (i.e. 21 days of yellow active tablets followed by 7 days of white placebo tablets). One tablet per day orally for 6 treatment cycles. | Drug | 30 mcg EE/150 mcg LNG |
| 20 mcg EE/3 mg DRSPAlso: 20 mcg ethinylestradiol and 3 mg drospirenone20 mcg EE combined with 3 mg DRSP administered in a 24/4-day regimen (i.e. 24 days of pink active tablets followed by 4 days of white placebo tablets). One tablet per day orally for 6 treatment cycles. | Drug | 20 mcg EE/3 mg DRSP |
Primary outcome
Plasma concentration of prothrombin fragment 1+2
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of APC resistance (ETP-based, APTT-based)
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of D-dimer
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of factor VII
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of factor VIII
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of von Willebrand factor
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of factor II
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of antithrombin
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of free and total Protein S
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of protein C
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of plasminogen activator inhibitor type-1 (PAI-1)
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of tissue type plasminogen activator (t-PA)
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of plasminogen
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of free tissue factor pathway inhibitor (TPFI)
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of E-selectin
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of fibrinogen
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of insulin
Time frame: At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of glucose
Time frame: At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of C-peptide
Time frame: At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for Cycles 3 and 6 (1 cycle = 28 days).
Plasma concentration of glycated hemoglobin (HbA1c)
Time frame: At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Homeostasis Model Assessment - Insulin Resistance (HOMA-IR)
Time frame: At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Oral glucose tolerance test (OGTT)
Time frame: At 0 (pre-glucose challenge), 30, 60, 90, 120 and 180 minutes after glucose challenge during pretreatment Cycle; at 0 (pre-glucose challenge), 30, 60, 90, 120 and 180 minutes after glucose challenge during Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of prolactin
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of follicle-stimulating hormone (FSH)
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of luteinizing hormone (LH)
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of estradiol (E2)
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of progesterone (P)
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of thyroïd stimulating hormone (TSH)
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of free thyroxine (fT3)/free triiodothyronine (fT4)
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of dihydroepiandrostenedione (DHEAS)
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of androstenedione
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of total testosterone (T)
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of dihydrotestosterone (DHT)
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of total cortisol
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of aldosterone
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of high density lipoprotein (HDL)-cholesterol
Time frame: At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of low density lipoprotein (LDL)-cholesterol
Time frame: At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of total cholesterol
Time frame: At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of triglycerides
Time frame: At screening, between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of lipoprotein (a)
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of apoliporotein A1
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of apoliporotein B
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of C-reactive protein
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of corticosteroid binding globulin (CBG)
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of sex hormone binding globulin (SHBG)
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of thyroxin binding globulin (TBG)
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
Serum concentration of angiotensinogen
Time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).
6 secondary outcomes
Number of subjects with adverse events as a measure of safety and tolerability
Time frame: From up to 28 days before randomization to maximum Day 4 of the Cycle 7 (1 cycle = 28 days).
Serum concentration of lactate dehydrogenase (LDH) 1 and 2
Time frame: Between Days 18 and 21 for the pretreatment Cycle and between Days 18 and 21 for the Cycle 6 (1 cycle = 28 days)
Serum concentration of tropinin T and I
Time frame: Between Days 18 and 21 for the pretreatment Cycle and between Days 18 and 21 for the Cycle 6 (1 cycle = 28 days)
Electrocardiogram (ECG) parameters
Time frame: At screening and between Days 18 and 21 for Cycle 6 (1 cycle = 28 days).
Echocardiographic parameters
Time frame: At screening and between Days 18 and 21 for Cycle 6 (1 cycle = 28 days).
Change from baseline to end of treatment in the different items of the menstrual distress questionnaires (MDQ) form C
Time frame: At pretreatment Cycle and between Days 18 and 21 for Cycle 6 (1 cycle = 28 days).
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 5 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Christine Klipping principal investigator
Dinox BV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 15 mg E4/3 mg DRSP, 30 mcg EE/150 mcg LNG and 20 mcg EE/3 mg DRSP in people with Contraception and Liver Metabolism, run by Estetra 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 25 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 5 Feb 2018. 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 combined 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.
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?
Plasma concentration of prothrombin fragment 1+2 (time frame: Between Days 18 and 21 for the pretreatment Cycle, and between Days 18 and 21 for the Cycles 3 and 6 (1 cycle = 28 days).). The study lists 47 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 5 Feb 2018.