Clinical trial · Interventional
Efficacy of Oral Contraceptive, Progesterone, and Inositol on Menstrual Regulation in PCOS
Comparison of the Efficacy of Oral Contraceptive, Progesterone, and Inositol Use in Regulating Menstrual Cycles in Patients With Polycystic Ovary Syndrome (PCOS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This cross-sectional study aims to compare the effectiveness of oral contraceptives, oral progesterone (didrogesterone), and inositol in regulating menstrual cycles among women diagnosed with polycystic ovary syndrome (PCOS). PCOS is a common endocrine disorder affecting reproductive-aged women and is associated with menstrual irregularities, hyperandrogenism, and polycystic ovarian morphology. While oral contraceptives are the mainstay of treatment, their use may be contraindicated in patients with cardiovascular risk factors, liver dysfunction, or in those who desire pregnancy. This study investigates whether oral progesterone and myo-inositol can serve as effective and safer alternatives for menstrual regulation and improvement of ovarian morphology and hyperandrogenic symptoms. A total of 150 women aged 15-40 years with a diagnosis of PCOS will be enrolled and divided into three equal groups: Group 1: Oral contraceptive users Group 2: Oral progesterone users Group 3: Inositol users The study will assess changes in menstrual regularity, ovarian morphology (via ultrasound), and clinical features such as hirsutism and acne before and after treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined Oral Contraceptive (Ethinylestradiol 0.03 mg + Drospirenone 3 mg) | Drug | — | UNRESOLVED |
| Dydrogesterone Pill | Drug | — | UNRESOLVED |
| Inositol mid-level volume | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Oral Contraceptive Group
- description
- Participants in this group will receive a combined oral contraceptive containing ethinylestradiol 0.03 mg and drospirenone 3 mg once daily for 21 days per cycle, followed by a 7-day pill-free interval, for 6 months. This arm serves as the active comparator to evaluate the relative efficacy of progesterone and myo-inositol therapy in menstrual regulation among women with PCOS.
- interventionNames
- Drug: Combined Oral Contraceptive (Ethinylestradiol 0.03 mg + Drospirenone 3 mg)
- type
- EXPERIMENTAL
- label
- Inositol Group
- description
- Participants will receive oral inositol 2g/day for 6 months. This arm will assess the ability of myo-inositol to restore ovulatory cycles, improve ovarian morphology, and reduce hyperandrogenic symptoms in PCOS compared with oral contraceptive and progesterone groups.
- interventionNames
- Dietary Supplement: Inositol mid-level volume
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Female participants aged 18 to 40 years. * Diagnosed with polycystic ovary syndrome (PCOS) according to the ESHRE/ASRM (Rotterdam) criteria (presence of at least two of the following: oligo/anovulation, clinical or biochemical hyperandrogenism, polycystic ovarian morphology). * No significant comorbid systemic disease. * Willingness to participate and ability to provide written informed consent. * Regular follow-up availability for at least 6 months. Exclusion Criteria: * Known hepatic, renal, cardiovascular, or endocrine disorders other than PCOS. * Pregnancy or current use of hormonal therapy within the past 3 months. * History of thromboembolic disease, breast cancer, or other contraindications to hormonal treatment. * Inability to adhere to follow-up visits or treatment regimen. * Severe cognitive or communication impairment that prevents proper consent or data collection. * Known allergy or hypersensitivity to any component of the study drugs. * Participation in another interventional study within the past 3 months.
References
Publications (0)
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