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About
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 years + 2 months.
Full 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 regimen (i.e. 24 days of active tablets followed by 4 days of placebo tablets [4-day hormone-free interval]). The study will include 6 visits:
At screening visit (Visit 1), informed consent will be signed by the participants and their parent(s) or legal representative(s) and the screening procedures will be performed. The site will also complete an Eligibility confirmation phone call to the participant after Visit 1. During the enrollment visit (Visit 2, between Days 12 and 19 of the pre-treatment cycle), eligibility criteria will be reviewed and the participant participation will be confirmed. Participants will be trained in the use of an electronic diary and will receive the study drug. A follow-up call will be performed after Visit 2, within 7 days following the first investigational product intake. Afterwards, the participants will attend 3 on-treatment visits at the clinical site [between Days 14 and 21 of the Cycle 1(Visit 3), Cycle 3 (Visit 4), and Cycle 6 (Visit 5)] and one visit after end of Cycle 6 (Visit 6).
For participants who consent to participate in a pharmacokinetics sub-study, blood samples for this sub-study will be taken at Visit 3 and Visit 5.
Adverse events will be followed throughout the study.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
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:
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:
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.]
Primary purpose
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145 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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