Status:
COMPLETED
Safety, Compliance and Pharmacokinetics of Estetrol Monohydrate/Drospirenone 15/3 mg in Post-menarchal Female Adolescents
Lead Sponsor:
Estetra
Conditions:
Safety
Eligibility:
FEMALE
12-17 years
Phase:
PHASE3
Brief Summary
To evaluate the safety, compliance, and pharmacokinetics profile of estetrol monohydrate (E4) 15 mg combined with drospirenone (DRSP) 3 mg in post-menarchal participants between the age of 12 and 17 y...
Detailed Description
This is a Phase 3, open-label, non-controlled study in healthy post-menarchal female participants who will be enrolled to receive once daily E4/DRSP 15/3 mg for six (6) 28-day cycles in a 24/4-day reg...
Eligibility Criteria
Inclusion
- Post-menarchal female participant requesting combined oral contraceptive (COC) either for contraceptive or for therapeutic use.
- Negative serum pregnancy test at screening and negative urine pregnancy test at enrollment.
- Aged 12 to 17 years and 2 months (inclusive) \[Estonia-specific: 15 to 17 years and 2 months (inclusive)\] at the time of signing the informed consent.
- Willing to use the investigational product for 6 consecutive cycles.
- Good physical and mental health on the basis of medical, surgical and gynecological history, physical examination, clinical laboratory, and vital signs.
- Body mass index (BMI) below or equal to the percentile 97 (P97) on the local pediatric BMI curves.
- Able to fulfill the requirements of the protocol, undergo all study procedures including e-diary and questionnaires completion.
- Having indicated the willingness to participate in the study by providing written assent.
- Having parent(s) or legal representative(s) willing and able to provide written informed consent.
Exclusion
- For participants who are not using hormonal contraception at screening, a menstrual cycle length shorter than 21 days or longer than 45 days.
- Currently using an injectable or a dermally implantable hormonal method of contraception.
- Known hypersensitivity to any of the investigational product ingredients.
- Currently pregnant or breastfeeding or with the intention to become pregnant during the course of the study.
- Less than 6 weeks since last delivery/2nd trimester abortion and before spontaneous menstruation has occurred following a delivery or 2nd trimester abortion.
- Any condition representing a contraindication / precaution to the use of COCs, including but not limited to:
- dyslipoproteinaemia,
- diabetes mellitus with vascular involvement (nephropathy, retinopathy, neuropathy, other),
- arterial hypertension (controlled and uncontrolled)
- personal or first-degree family history of deep vein thrombosis or pulmonary embolism,
- current or planned prolonged immobilization,
- known inherited or acquired hypercoagulopathies or thrombogenic mutations (e.g. Factor V Leiden mutation),
- current treatment with anticoagulants,
- presence or history of arterial thromboembolism,
- complicated valvular heart disease,
- systemic lupus erythematosus,
- presence or history of migraine with aura,
- symptomatic gallbladder disease,
- porphyria.
- Within the past 6 months, undiagnosed (unexplained) abnormal vaginal bleeding, or any abnormal bleeding that could possibly recur during the study.
- Presence or history of recurrent pelvic inflammatory disease.
- Any clinically relevant lower genital tract infection (including gonorrhea and chlamydia infections) until successfully treated, in the opinion of the Investigator.
- Presence or history of hepatic disease as long as liver function values have not returned to normal.
- Renal impairment
- 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).
- History of organ transplantation within 5 years before screening or chronic disease potentially necessitating organ transplantation during the anticipated course of the study.
- Presence or history of sex hormone-related malignancy.
- History of non-hormone-related malignancy within 5 years before screening.
- Current regular use or regular use within 1 month prior to Visit 2 of drugs potentially triggering interactions with COCs including but not limited to:
- Cytochrome P450 3A4 (CYP 3A4) inducers: barbiturates, primidone, bosentan, felbamate, griseofulvin, oxcarbazepine, topiramate, carbamazepine, phenytoin, rifampicin, St John's wort (Hypericum perforatum L).
- CYP 3A4 inhibitors: azole antifungals excluding topical fluconazole, phenylbutazone, modafinil, cimetidine, verapamil, macrolides excluding azithromycin, diltiazem and grapefruit juice.
- Human immunodeficiency virus (HIV)/Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors.
- History of alcohol or drug abuse (including laxatives) within 12 months prior to screening.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs.
- Uncontrolled thyroid disorders.
- 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.
- Sponsor, Contract Research Organization (CRO) or Investigator's site personnel directly affiliated with this study.
- The participant is judged by the Investigator to be unsuitable for any reason.
- \[Estonia-specific: Subjects who are at a gynecologist visit for the first time in their life may not sign the informed consent during this first visit.\]
Key Trial Info
Start Date :
December 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2023
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT04792385
Start Date
December 28 2020
End Date
November 24 2023
Last Update
December 22 2023
Active Locations (23)
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1
KVL Medical Office/KVL Arstikabinet
Pärnu, Estonia
2
East-Tallinn Central Hospital
Tallinn, Estonia
3
Sexual Health Clinic, Tallinn
Tallinn, Estonia
4
Sexual Health Clinic, Tartu
Tartu, Estonia