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ContraceptionPhase 4NCT06067256

A Multicentre, Prospective, Open-label, Non-comparative Study

A Phase 4 study testing Female Contraceptive in people with Contraception, run by Italfarmaco at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

As there are no recent studies conducted in Italy on the profile of this COC, the purpose of this study is to evaluate its efficacy and tolerability in a given subset of women residing in Italy that are in need of contraception. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
Female Contraceptive
How many people
228 participants
Where
1 siteItaly
Study dates
20 Jul 2023to Jun 2024
Phase
Phase 4
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 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • All the following criteria must be met.
  • Healthy women aged between 18 and 35 years (inclusive) in need of contraception.
  • Subjects residing in Italy and having a good knowledge of the Italian language, such as to correctly understand the Informed Consent Form, the instructions for use, and to ensure potential adhesion to the study.
  • Subjects providing written Informed Consent Form.
  • Subjects willing to comply with the study protocol.

Who cannot join

  • Subjects who meet even one of the following criteria will be excluded from the study.
  • Subjects presenting any contraindications to the use of Combined Oral Contraceptives (COC) according to the current Summary of Product Characteristics (SmPC) of Effimia®, i.e. subjects presenting (or have ever presented) myocardial infarction, transient ischemic attack (TIA), stroke, angina pectoris, deep vein thrombosis (DVT), pulmonary embolism (PE) (or presence of blood clot in other organs than legs and lungs), any blood clotting disorder (such as protein C deficiency, protein S deficiency, antithrombin-III deficiency), or subjects that need to undergo surgery or that have to lie down for a long period of time (including the risk of previous deep vein thrombosis (DVT), arterial thromboembolism (ATE), hypertension in course of treatment and diabetes). If any of the listed conditions should appear during the use of the tested COC, the product must be stopped immediately, and the subject withdrawn from the study.
  • Subjects presenting severe diabetes with blood vessel damages, heart valve disease with complications, severe hypertension, severe hypercholesterolemia, or hypertriglyceridemia, hyperhomocysteinaemia, migraine with aura, hepatitis C (and taking medications for this condition), endometrial hyperplasia, unexplained vaginal bleeding, that are breastfeeding or pregnant or that are suspecting a pregnancy.
  • Subjects presenting (or have ever presented) any liver disease not yet recovered (liver function not yet normalized), any benign or malignant tumour of the liver, any breast or genital organs cancer (even suspected), jaundice during pregnancy or while using hormonal contraceptives.
  • Subjects presenting galactose intolerance, total lactase deficiency or glucosegalactose malabsorption syndrome.
  • Subjects presenting hypersensitivity to the active substances or to any excipients of the tested COC (e.g., norgestimate, ethinylstradiol or lactose).
Show all 13Show fewer
  • Subjects using the following not allowed treatments during the whole study period (according to the SmPC of the Investigational Medicinal Product - IMP): treatments for tuberculosis (e.g. rifampicin), for epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine), for HIV and hepatitis C virus infection (protease inhibitor drugs and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz and also ombitasvir, paritaprevir, ritonavir and dasabuvir), for fungal infections (e.g. griseofulvin), for arthritis, for osteoarthritis (etoricoxib ), for pulmonary arterial hypertension (bosentan) and St. John's wort used as an antidepressant. Medicines containing cyclosporine, the antiepileptic lamotrigine, tranexamic acid, theophylline (used to treat respiratory problems) and tizanidine (used to treat muscle pain and / or cramps) should not be taken as well.
  • Subjects who have used hormonal contraceptives in the previous month.
  • Subjects presenting a Body Mass Index - BMI ≥ 30 kg/m2 (class I obesity).
  • Subjects smoking > 15 cigarettes per day.
  • Subjects using COC off-label (e.g., for polycystic ovarian syndrome - PCOS, endometriosis, or recurrent menometrorrhagia).
  • Subjects currently taking part or who took part in clinical studies with experimental products in the previous month.
  • Subjects showing incapacity / inability to comply with the study protocol (unreliability in the intake of the product or in the completion of the diary) according to the Investigator's opinion.

Trial locations and contacts

1 site in 1 country.

Roberto Piazza, MD contact

+39 0264432516

r.piazza@italfarmaco.com

Italy1 site, 1 recruiting

  • IRCCS Ospedale Policlinico

    San Martino, Genova

    Angelo Cagnacci, MD

    Recruiting

Other trials in Italy

About this study

Official title: A Multicentre, Prospective, Open-label, Non-comparative Study to Evaluate Menstrual Bleeding Typology, Tolerability, and Compliance During a Monophasic Hormonal Contraceptive Treatment With Norgestimate + Ethinylestradiol in Italy.

As there are no recent studies conducted in Italy on the profile of this COC, the purpose of this study is to evaluate its efficacy and tolerability in a given subset of women residing in Italy that are in need of contraception. Evaluate the cycle control: breakthrough bleeding (bleeding and/or spotting between cyclically regular onset of menses) of monophasic oral contraceptive pill Effimia® (NGM250 + EE35) in a population of women residing in Italy.

Conditions
Contraception
Being tested
Female Contraceptive
Keywords
Female contraception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Female ContraceptiveDrug

    Effimia® exerts its action by means of a gonadotropin suppression mechanism through the estrogenic and progestin action exerted by EE and NGM. The contraceptive effect of Effimia® is based on the interaction of various factors, the most important of which consist of ovulation inhibition and endometrial modifications.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cycle control evaluation parameter

    breakthrough bleeding (bleeding and/or spotting between cyclically regular onset of menses) by calculating the intermenstrual spotting occurrence rate at sixth cycle only (value to be intended as not cumulative with values from the other 5 cycles taking place during the whole study period). A comparison within group will be performed at V3 with respect to Baseline (V1)

    Measured: 180 days

Secondary outcomes (8)

  1. Cycle control evaluation parameters

    frequency, duration, regularity, flow volume (subject determined), unscheduled bleeding. A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).

    Measured: 180 days

  2. Global Acne Grading System (GAGS).

    A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).

    Measured: 180 days

  3. Profile of Mood State (POMS).

    A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).

    Measured: 180 days

  4. Female Sexual Function Index (FSFI).

    A comparison within group will be performed at V2 and V3 with respect to Baseline (V1).

    Measured: 180 days

  5. Dysmenorrhea - VAS scale.

    A comparison within group will be performed at V2 and V3 with respect to Baseline (V1)

    Measured: 180 days

  6. Compliance

    Adherence to treatment

    Measured: 180 days

  7. Contraception failure rate during the 6-month treatment

    the contraception failure rate is defined as the proportion of women who will become pregnant during the study period. The reasons for any contraception failure occurrence will be identified and listed (e.g., discontinuation or poor compliance).

    Measured: 180 days

  8. Metabolic and hormonal parameters

    blood lipid and glucose parameters (total cholesterol, High Density Lipoprotein - Cholesterol HDL-C, Low Density Lipoprotein - Cholesterol LDL-C, triglycerides, total testosterone, dehydroepiandrosterone - DHEAS, androstenedione, glucose, insulin, Sex Hormone Binding Globulin - SHBG) and hyperandrogenism (Free Androgenicity Index - FAI) - only in a subgroup of 28 subjects recruited only in the centre of Genova. They will be evaluated in comparison with Baseline (V1).

    Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2023
  2. Study start20 Jul 2023
  3. Primary completionDec 2023 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

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 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
228 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06067256
Sponsor's protocol ID
EFFI2021/01
Status last verified
Sep 2023
First submitted
28 Sep 2023
Last updated
4 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mosher WD, Martinez GM, Chandra A, Abma JC, Willson SJ. Use of contraception and use of family planning services in the United States: 1982-2002. Adv Data. 2004 Dec 10;(350):1-36.

    PubMed 15633582

  • Trussell J. Contraceptive failure in the United States. Contraception. 2011 May;83(5):397-404. doi: 10.1016/j.contraception.2011.01.021. Epub 2011 Mar 12.

    PubMed 21477680

  • Brynhildsen J. Combined hormonal contraceptives: prescribing patterns, compliance, and benefits versus risks. Ther Adv Drug Saf. 2014 Oct;5(5):201-13. doi: 10.1177/2042098614548857.

    PubMed 25360241

  • Sitruk-Ware R, Nath A. Characteristics and metabolic effects of estrogen and progestins contained in oral contraceptive pills. Best Pract Res Clin Endocrinol Metab. 2013 Feb;27(1):13-24. doi: 10.1016/j.beem.2012.09.004. Epub 2012 Oct 10.

    PubMed 23384742

  • European Medicines Agency Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks - CHMP endorses PRAC recommendation EMA/709120/2013 Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/11/news_d etail_001969.jsp&mid=WC0b01ac058004d5c1

  • Phillips A, Hahn DW, McGuire JL. Preclinical evaluation of norgestimate, a progestin with minimal androgenic activity. Am J Obstet Gynecol. 1992 Oct;167(4 Pt 2):1191-6. doi: 10.1016/s0002-9378(12)90410-x.

    PubMed 1415445

  • Bottiger LE, Boman G, Eklund G, Westerholm B. Oral contraceptives and thromboembolic disease: effects of lowering oestrogen content. Lancet. 1980 May 24;1(8178):1097-101. doi: 10.1016/s0140-6736(80)91550-0.

    PubMed 6103437

  • Goldzieher JW. Selected aspects of the pharmacokinetics and metabolism of ethinyl estrogens and their clinical implications. Am J Obstet Gynecol. 1990 Jul;163(1 Pt 2):318-22. doi: 10.1016/0002-9378(90)90575-r.

    PubMed 2196804

  • Gallo MF, Nanda K, Grimes DA, Lopez LM, Schulz KF. 20 microg versus >20 microg estrogen combined oral contraceptives for contraception. Cochrane Database Syst Rev. 2013 Aug 1;2013(8):CD003989. doi: 10.1002/14651858.CD003989.pub5.

    PubMed 23904209

  • Van Vliet HA, Raps M, Lopez LM, Helmerhorst FM. Quadriphasic versus monophasic oral contraceptives for contraception. Cochrane Database Syst Rev. 2011 Nov 9;(11):CD009038. doi: 10.1002/14651858.CD009038.pub2.

    PubMed 22071862

  • Runnebaum B, Grunwald K, Rabe T. The efficacy and tolerability of norgestimate/ethinyl estradiol (250 micrograms of norgestimate/35 micrograms of ethinyl estradiol): results of an open, multicenter study of 59,701 women. Am J Obstet Gynecol. 1992 Jun;166(6 Pt 2):1963-8. doi: 10.1016/0002-9378(92)91396-r.

    PubMed 1605286

  • National Research Council (US) Committee on Population. Contraception and Reproduction: Health Consequences for Women and Children in the Developing World. Washington (DC): National Academies Press (US); 1989. Available from http://www.ncbi.nlm.nih.gov/books/NBK235072/

    PubMed 25144060

  • Dayal M, Barnhart KT. Noncontraceptive benefits and therapeutic uses of the oral contraceptive pill. Semin Reprod Med. 2001 Dec;19(4):295-303. doi: 10.1055/s-2001-18637.

    PubMed 11727171

  • PASS 2021 Power Analysis and Sample Size Software (2021). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass

  • Doshi A, Zaheer A, Stiller MJ. A comparison of current acne grading systems and proposal of a novel system. Int J Dermatol. 1997 Jun;36(6):416-8. doi: 10.1046/j.1365-4362.1997.00099.x. No abstract available.

    PubMed 9248884

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Female Contraceptive in people with Contraception, run by Italfarmaco at 1 site in Italy.

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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 4 Oct 2023. 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 Italy. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Roberto Piazza, MD (+39 0264432516, r.piazza@italfarmaco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cycle control evaluation parameter (time frame: 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06067256, which also lists 34 linked publications.

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 4 Oct 2023.

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