A clinical study to investigate the safety, compliance and pharmacokinetics of a combined oral contraceptive in teenage girls who have a menstrual cycle.
- Conditions
- ContraceptionMedDRA version: 21.1Level: LLTClassification code 10030971Term: Oral contraceptiveSystem Organ Class: 100000004865Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2019-003002-27-FI
- Lead Sponsor
- Estetra SR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 100
1.Post-menarchal female subject requesting COC either for contraceptive or for therapeutic use.
2.Negative serum pregnancy test at screening and negative urine pregnancy test at enrollment.
3.Aged 12 to 17 years and 2 months (inclusive) at the time of signing the IC.
4.Willing to use the IP for 6 consecutive cycles.
5.Good physical and mental health on the basis of medical, surgical and gynecological history, physical examination, clinical laboratory, and vital
signs.
6.Body mass index (BMI) below or equal to the percentile 97 (P97) on the local pediatric BMI curves.
Additional inclusion criteria for pharmacokinetics sub-study :
1.BMI below or equal to the percentile 95 (P95) on the local pediatric BMI curves.
2.Subjects are aware and willing to comply with the following restrictions prior to blood sampling for pharmacokinetic assessment:
a.The subject should be fasting for 8 hours minimum at the time of blood sampling.
b.On days when blood sampling for pharmacokinetics is scheduled, the subject should not take the investigational product prior to the blood sampling.
c.The subject should not smoke during the 30 minutes prior to the blood sampling.
d.The subject should not perform any physical activity during the 2 hours prior to the blood sampling.
7.Able to fulfill the requirements of the protocol, undergo all study procedures including e-diary and questionnaires completion.
8.Having indicated the willingness to participate in the study by providing written assent.
9.Having parent(s) or legal representative(s) willing and able to provide written IC.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.For subjects who are not using hormonal contraception at screening, a menstrual cycle length shorter than 21 days or longer than 45 days.
2.Currently using an injectable or a dermally implantable hormonal method of contraception.
3.Known hypersensitivity to any of the IP ingredients.
4.Currently pregnant or breastfeeding or with the intention to become pregnant during the course of the study.
5.Less than 6 weeks since last delivery/2nd trimester abortion and before spontaneous menstruation has occurred following a delivery or 2nd trimester abortion.
6.Any condition representing a contraindication / precaution to the use of COCs.
7.Within the past 6 months, undiagnosed (unexplained) abnormal vaginal bleeding, or any abnormal bleeding that could possibly recur during the study.
8.Presence or history of recurrent pelvic inflammatory disease.
9.Any clinically relevant lower genital tract infection (including gonorrhea and chlamydia infections) until successfully treated, in the opinion of the Investigator.
10.Presence or history of hepatic disease as long as liver function values have not returned to normal.
11.Renal impairment (glomerular filtration rate (GFR) < 60 mL/min/1.73m²).
12.Hyperkalemia or presence of conditions that predispose to hyperkalemia such as renal impairment, hepatic impairment, adrenal insufficiency and daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium concentration (e.g. angiotensin-converting-enzyme (ACE) inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonist and non-steroidal anti-inflammatory drugs).
13.History of organ transplantation within 5 years before screening or chronic disease potentially necessitating organ transplantation during the anticipated course of the study.
14.Presence or history of sex hormone-related malignancy.
15.History of non-hormone-related malignancy within 5 years before screening.
16.Current regular use or regular use within 1 month prior to Visit 2 of drugs potentially triggering interactions with COCs.
17.History of alcohol or drug abuse (including laxatives) within 12 months prior to screening.
18.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs. The Investigator should exercise medical judgment in consideration of the subject’s medical history and/or clinical or laboratory evidence of any of the following:
a. cystic fibrosis, celiac disease, inflammatory bowel disease, gastritis, ulcers, gastrointestinal or rectal bleeding,
b. major gastrointestinal tract surgery (this does not include history of appendectomy),
c. pancreatic injury or pancreatitis,
d. liver disease or liver injury as indicated by abnormal liver function tests,
e. impaired renal function if considered as clinically significant,
f. abnormal urinary constituents (e.g. albumin if considered as clinically significant).
19.Uncontrolled thyroid disorders.
20.Participation in another investigational drug clinical study within 1 month (30 days) or have received an investigational drug within the last month (30 days) prior to screening.
21.Sponsor, Contract Research Organization (CRO) or Investigator’s site personnel directly affiliated with this study.
22.The subject is judged by the Investigator to be unsuitable for any reason.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method